Audit day #2 - Korean version of the FDA
Got pulled in to defend my work 2x.. Did awesome
Then had to defend someone elses work from 9 years ago (sight unseen) ... It went horrible. They told me I'm wasting their time and to get out. I said no problem with a big smile.
Then they called me back about 2 hours later and asked did I have time to review the data? 2nd time went much better... But I don't want to talk to them a 3rd time. It's reignited my hatred for Asians.
There we go
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Digital Masta
- Posts: 1574
- Joined: Tue Nov 19, 2019 10:56 pm
Re: There we go
So they went after you just for trying to defend work from a decade ago that you had nothing to do with? That's crazy.
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
The issue isn't defending the old work generally. The issue is that I was blindsided by it. If I'm allowed to sit down and read the document I can explain the testing. If I looking at it 5 seconds before you... I dont know what's in it either.
They got mad that THEY asked me to defend it.. But I wasn't prepared and well versed in the 14 seconds it took to pass it around the table.
In other news.
Still waiting for my car to be shipped. Going with a 2021 Honda Passport Touring AWD through Carmax. Sold $45k in investments and transferred into the checking account - car + warranty + fees will be right at $36k.
They got mad that THEY asked me to defend it.. But I wasn't prepared and well versed in the 14 seconds it took to pass it around the table.
In other news.
Still waiting for my car to be shipped. Going with a 2021 Honda Passport Touring AWD through Carmax. Sold $45k in investments and transferred into the checking account - car + warranty + fees will be right at $36k.
Re: There we go
Almost caught up with Bleach, Aiden Souske is back in the scene. Man I forgot how much I love Aizen lol. I wish Kubo made some way to free him.
Am I the only one enjoying Dragon Ball Daima here?
Am I the only one enjoying Dragon Ball Daima here?
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
Day 3 of the audit went much better for me.
Got called in to speak about the project that was specifically assigned to me when I started 3 years ago. Off to a rocky start. They asked me to bring the final report and binders. In reality, there were 11 binders to the document...my dumb ass brought 4 and didn't even think about it. He asked questions. I answered quickly, decisively, and confidently. He asked to see the original test protocol. I couldn't find it. I thought WTF? Oooooooh - I didn't bring all of the binders. Went back and grabbed 2 more. We talked more. Very cool, calm, collected. He asked "Where is the rest of the raw data? This is only part 1?"
OOoooooooooh shit - you're right....excuse me. Someone else came with me and we brought the other 6 binders. I felt so fucking stupid. I was furious with me. It was a project that was started and handed to me. I KNEW that the data was stored in 2 separate places. I KNEW there were 11 binders in total. But I was nervous when called, so didn't think about it.
We didn't finish and will likely revisit first thing in the AM. I think am ready though
-- we'll see.
Got called in to speak about the project that was specifically assigned to me when I started 3 years ago. Off to a rocky start. They asked me to bring the final report and binders. In reality, there were 11 binders to the document...my dumb ass brought 4 and didn't even think about it. He asked questions. I answered quickly, decisively, and confidently. He asked to see the original test protocol. I couldn't find it. I thought WTF? Oooooooh - I didn't bring all of the binders. Went back and grabbed 2 more. We talked more. Very cool, calm, collected. He asked "Where is the rest of the raw data? This is only part 1?"
OOoooooooooh shit - you're right....excuse me. Someone else came with me and we brought the other 6 binders. I felt so fucking stupid. I was furious with me. It was a project that was started and handed to me. I KNEW that the data was stored in 2 separate places. I KNEW there were 11 binders in total. But I was nervous when called, so didn't think about it.
We didn't finish and will likely revisit first thing in the AM. I think am ready though
-- we'll see.Re: There we go
Is this a normal routine audit or did someone get on trouble and an audit is the result?killacross wrote: ↑Thu Dec 12, 2024 7:33 am Day 3 of the audit went much better for me.
Got called in to speak about the project that was specifically assigned to me when I started 3 years ago. Off to a rocky start. They asked me to bring the final report and binders. In reality, there were 11 binders to the document...my dumb ass brought 4 and didn't even think about it. He asked questions. I answered quickly, decisively, and confidently. He asked to see the original test protocol. I couldn't find it. I thought WTF? Oooooooh - I didn't bring all of the binders. Went back and grabbed 2 more. We talked more. Very cool, calm, collected. He asked "Where is the rest of the raw data? This is only part 1?"
OOoooooooooh shit - you're right....excuse me. Someone else came with me and we brought the other 6 binders. I felt so fucking stupid. I was furious with me. It was a project that was started and handed to me. I KNEW that the data was stored in 2 separate places. I KNEW there were 11 binders in total. But I was nervous when called, so didn't think about it.
We didn't finish and will likely revisit first thing in the AM. I think am ready though
Edit
CNN rescuing an Asad Syrian prisoner who was in prison for 3 months is amazing...... and of course my PM Trudeau is a devotee feminist.
Re: There we go
Wait, this isn't about the Vax poison Pharma is pushing?killacross wrote: ↑Thu Dec 12, 2024 7:33 am Day 3 of the audit went much better for me.
Got called in to speak about the project that was specifically assigned to me when I started 3 years ago. Off to a rocky start. They asked me to bring the final report and binders. In reality, there were 11 binders to the document...my dumb ass brought 4 and didn't even think about it. He asked questions. I answered quickly, decisively, and confidently. He asked to see the original test protocol. I couldn't find it. I thought WTF? Oooooooh - I didn't bring all of the binders. Went back and grabbed 2 more. We talked more. Very cool, calm, collected. He asked "Where is the rest of the raw data? This is only part 1?"
OOoooooooooh shit - you're right....excuse me. Someone else came with me and we brought the other 6 binders. I felt so fucking stupid. I was furious with me. It was a project that was started and handed to me. I KNEW that the data was stored in 2 separate places. I KNEW there were 11 binders in total. But I was nervous when called, so didn't think about it.
We didn't finish and will likely revisit first thing in the AM. I think am ready though
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
No - I work in contrast media now (the solution they inject or your drink for MRIs, CAT scans, Xrays)...significantly easier.
No one did anything to trigger this audit. This is the Korean FDA. But every country/region has their own auditing authority. The big thing was a few years ago when there was an agreement announced that regulatory agencies would lean on eachother to cut down on some of the regulation. It is still on the books, but is still pretty short lived - countries/regions don't trust eachother.
Day 4 of the Audit
I rocked this morning. Went in to speak on my project and answered questions excellently. Knew my info inside and out. I left the room. Got called back to discuss another one of my projects. Rocked that one as well too. Started smelling myself a bit...
Later in the day - these mother fuckers pissed me off. My boss was talking to one auditor in one room. He leaves to get some documents, but instead gets called into another room. He goes to that room and stays for like 2 hours. I am walking down the hallway - and someone [a lady] stops me and says "Killa, we need you to speak to the authorities here" I asked, "Speak about what? I haven't been prepared to speak on anything." She goes - I'm not sure, the binders and data are in the room here...let me grab it. She opens the door and goes - "Here is killa, I brought him to discuss this". All eyes shift on me. I apologize and say taht I was not prepared or informed as to the subject, so I am unsure if I can be of help. The manager says...no, no, no - it's perfectly fine. Come in and have a seat and we can discuss and lead the conversation. The authorities just look at me blankly. The manager says to introduce yourself and what you do. I give my name and title. They look at me blankly. They didn't ask me any questions and just kept saying that I can present anything that I would like. I said I am unsure as to what they would like to discuss - so they say I can present anything. I look at the table of documents and say, "well this is one of my current projects here - we can discuss this." They told me no...we have already reviewed that and have no interest in revisitng. I asked, is there any area in particular you are concerned with? Maybe I can clarify some of your confusion. The inspector is just instantly pissed, turns bright red, and just starts talking to the translator. The translator is like - we were talking to the other gentleman (my manager) earlier and we were talking in depth. We do not want to revisit the entire conversation with you a second time. At this point, you are just wasting our time and we are very unhappy. We would like for you to find a document for any equipment that was brought online in the past year or two, and be ready to present that first thing tomorrow morning. That is your homework.
I said No problem and leave the room. As I walk out - I see the first lady who invited me into the room. She looks at me and start Yack Yack Yacking it up. I said "I don't think that was particular funny." She goes "I'm not laughing at you, just at how unorganized and chaotic this all is". I said "No, this has nothing to do with the audit, you just set me up. I don't understand, what was the point of that?" She starts laughing again and said - you did fine.
I go back to the prep room (where I was assigned) and they look at me sideways. The entire conversation is transcribed and they ask me why I was called into the room. I said I have no idea either - the lady said that she would get me some info...but instead blindsided me. What the fuck was that?
They were like - we're not sure either.
If I cared more...I would be like - mother fuck that lady. But I am the guy at work that is known for 2 things. I have a great attitude, and I have the best saying: When they ask me why I don't let most things at work bother me...I tell them. When it comes to work - I can do smart things, I can do dumb things; I can be productive, I can accomplish nothing; I can be efficient, or I can waste time. It doesn't matter. I can be happy and have a pleasant day...or I can be angry and disgruntled and talk about how much I hate this place and how much I hate these people. It All pays the same.
But still - fuck that bitch!!
No one did anything to trigger this audit. This is the Korean FDA. But every country/region has their own auditing authority. The big thing was a few years ago when there was an agreement announced that regulatory agencies would lean on eachother to cut down on some of the regulation. It is still on the books, but is still pretty short lived - countries/regions don't trust eachother.
Day 4 of the Audit
I rocked this morning. Went in to speak on my project and answered questions excellently. Knew my info inside and out. I left the room. Got called back to discuss another one of my projects. Rocked that one as well too. Started smelling myself a bit...
Later in the day - these mother fuckers pissed me off. My boss was talking to one auditor in one room. He leaves to get some documents, but instead gets called into another room. He goes to that room and stays for like 2 hours. I am walking down the hallway - and someone [a lady] stops me and says "Killa, we need you to speak to the authorities here" I asked, "Speak about what? I haven't been prepared to speak on anything." She goes - I'm not sure, the binders and data are in the room here...let me grab it. She opens the door and goes - "Here is killa, I brought him to discuss this". All eyes shift on me. I apologize and say taht I was not prepared or informed as to the subject, so I am unsure if I can be of help. The manager says...no, no, no - it's perfectly fine. Come in and have a seat and we can discuss and lead the conversation. The authorities just look at me blankly. The manager says to introduce yourself and what you do. I give my name and title. They look at me blankly. They didn't ask me any questions and just kept saying that I can present anything that I would like. I said I am unsure as to what they would like to discuss - so they say I can present anything. I look at the table of documents and say, "well this is one of my current projects here - we can discuss this." They told me no...we have already reviewed that and have no interest in revisitng. I asked, is there any area in particular you are concerned with? Maybe I can clarify some of your confusion. The inspector is just instantly pissed, turns bright red, and just starts talking to the translator. The translator is like - we were talking to the other gentleman (my manager) earlier and we were talking in depth. We do not want to revisit the entire conversation with you a second time. At this point, you are just wasting our time and we are very unhappy. We would like for you to find a document for any equipment that was brought online in the past year or two, and be ready to present that first thing tomorrow morning. That is your homework.
I said No problem and leave the room. As I walk out - I see the first lady who invited me into the room. She looks at me and start Yack Yack Yacking it up. I said "I don't think that was particular funny." She goes "I'm not laughing at you, just at how unorganized and chaotic this all is". I said "No, this has nothing to do with the audit, you just set me up. I don't understand, what was the point of that?" She starts laughing again and said - you did fine.
I go back to the prep room (where I was assigned) and they look at me sideways. The entire conversation is transcribed and they ask me why I was called into the room. I said I have no idea either - the lady said that she would get me some info...but instead blindsided me. What the fuck was that?
They were like - we're not sure either.
If I cared more...I would be like - mother fuck that lady. But I am the guy at work that is known for 2 things. I have a great attitude, and I have the best saying: When they ask me why I don't let most things at work bother me...I tell them. When it comes to work - I can do smart things, I can do dumb things; I can be productive, I can accomplish nothing; I can be efficient, or I can waste time. It doesn't matter. I can be happy and have a pleasant day...or I can be angry and disgruntled and talk about how much I hate this place and how much I hate these people. It All pays the same.
But still - fuck that bitch!!
Re: There we go
Nah nah nah, don't let that shit slide bruh, no matter what image you try to uphold at work, it's about principle and they will keep doing it over again. But ya fuck that bitch. Is she black, white, Asian? Same with your manager? No big deal, just curious.killacross wrote: ↑Fri Dec 13, 2024 1:40 am No - I work in contrast media now (the solution they inject or your drink for MRIs, CAT scans, Xrays)...significantly easier.
No one did anything to trigger this audit. This is the Korean FDA. But every country/region has their own auditing authority. The big thing was a few years ago when there was an agreement announced that regulatory agencies would lean on eachother to cut down on some of the regulation. It is still on the books, but is still pretty short lived - countries/regions don't trust eachother.
Day 4 of the Audit
I rocked this morning. Went in to speak on my project and answered questions excellently. Knew my info inside and out. I left the room. Got called back to discuss another one of my projects. Rocked that one as well too. Started smelling myself a bit...
Later in the day - these mother fuckers pissed me off. My boss was talking to one auditor in one room. He leaves to get some documents, but instead gets called into another room. He goes to that room and stays for like 2 hours. I am walking down the hallway - and someone [a lady] stops me and says "Killa, we need you to speak to the authorities here" I asked, "Speak about what? I haven't been prepared to speak on anything." She goes - I'm not sure, the binders and data are in the room here...let me grab it. She opens the door and goes - "Here is killa, I brought him to discuss this". All eyes shift on me. I apologize and say taht I was not prepared or informed as to the subject, so I am unsure if I can be of help. The manager says...no, no, no - it's perfectly fine. Come in and have a seat and we can discuss and lead the conversation. The authorities just look at me blankly. The manager says to introduce yourself and what you do. I give my name and title. They look at me blankly. They didn't ask me any questions and just kept saying that I can present anything that I would like. I said I am unsure as to what they would like to discuss - so they say I can present anything. I look at the table of documents and say, "well this is one of my current projects here - we can discuss this." They told me no...we have already reviewed that and have no interest in revisitng. I asked, is there any area in particular you are concerned with? Maybe I can clarify some of your confusion. The inspector is just instantly pissed, turns bright red, and just starts talking to the translator. The translator is like - we were talking to the other gentleman (my manager) earlier and we were talking in depth. We do not want to revisit the entire conversation with you a second time. At this point, you are just wasting our time and we are very unhappy. We would like for you to find a document for any equipment that was brought online in the past year or two, and be ready to present that first thing tomorrow morning. That is your homework.
I said No problem and leave the room. As I walk out - I see the first lady who invited me into the room. She looks at me and start Yack Yack Yacking it up. I said "I don't think that was particular funny." She goes "I'm not laughing at you, just at how unorganized and chaotic this all is". I said "No, this has nothing to do with the audit, you just set me up. I don't understand, what was the point of that?" She starts laughing again and said - you did fine.
I go back to the prep room (where I was assigned) and they look at me sideways. The entire conversation is transcribed and they ask me why I was called into the room. I said I have no idea either - the lady said that she would get me some info...but instead blindsided me. What the fuck was that?
They were like - we're not sure either.
If I cared more...I would be like - mother fuck that lady. But I am the guy at work that is known for 2 things. I have a great attitude, and I have the best saying: When they ask me why I don't let most things at work bother me...I tell them. When it comes to work - I can do smart things, I can do dumb things; I can be productive, I can accomplish nothing; I can be efficient, or I can waste time. It doesn't matter. I can be happy and have a pleasant day...or I can be angry and disgruntled and talk about how much I hate this place and how much I hate these people. It All pays the same.
But still - fuck that bitch!!
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
I have a white guy boss. The lady was white too (she works in scheduling).
Never thought of it - my department is incredibly diverse...though DEI doesn't particularly matter. I have a white guy boss - 40, I [Black guy-40] am #2, Ms Thickums [Puerto Rican with lady parts-43] is #3, then a white guy-28 and an Indian guy-26 are the juniors. We are waiting for the new year then they can post for 2 more positions. I think I will aim towards another girl...but not a Latina - so I can keep Ms Thickums to myself
It's important that you get angry in the moment, but #1 control yourself, and #2 never take it personal. It is manly.
Audits always have someone who gets set up to take those lumps; it's the nature of the beast. I just don't like that it was me this time. When you do it to yourself (like I did before with forgetting the binders) you can get upset with yourself. When someone else does it to you - you get pissed in teh moment, then learn to let it go. I've been in this industry and doing these things for years now...
Never thought of it - my department is incredibly diverse...though DEI doesn't particularly matter. I have a white guy boss - 40, I [Black guy-40] am #2, Ms Thickums [Puerto Rican with lady parts-43] is #3, then a white guy-28 and an Indian guy-26 are the juniors. We are waiting for the new year then they can post for 2 more positions. I think I will aim towards another girl...but not a Latina - so I can keep Ms Thickums to myself
It's important that you get angry in the moment, but #1 control yourself, and #2 never take it personal. It is manly.
Audits always have someone who gets set up to take those lumps; it's the nature of the beast. I just don't like that it was me this time. When you do it to yourself (like I did before with forgetting the binders) you can get upset with yourself. When someone else does it to you - you get pissed in teh moment, then learn to let it go. I've been in this industry and doing these things for years now...
Last edited by killacross on Fri Dec 13, 2024 10:35 am, edited 1 time in total.
Re: There we go
Very true, we all take our lumps that I know. I'm planning for a big maintenance job this weekend. All the lumps will be solely on me.
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
Oh my geezus... Halfway through day 5. It is going ROUGH!!
It's so bad
.. And it completely came outta nowhere! Not my portion. But my department. My manager was almost in tears. Almost. I pretended I didn't see it though...becaise I'm not like that. Who knows what's going on at home. I'm just not trying to catch those stray bullets. Need to be on that warning group text
"Stay away today!!"
It's so bad
.. And it completely came outta nowhere! Not my portion. But my department. My manager was almost in tears. Almost. I pretended I didn't see it though...becaise I'm not like that. Who knows what's going on at home. I'm just not trying to catch those stray bullets. Need to be on that warning group text
"Stay away today!!"
Re: There we go
What did he do?killacross wrote: ↑Fri Dec 13, 2024 5:29 pm Oh my geezus... Halfway through day 5. It is going ROUGH!!
It's so bad
.. And it completely came outta nowhere! Not my portion. But my department. My manager was almost in tears. Almost. I pretended I didn't see it though...becaise I'm not like that. Who knows what's going on at home. I'm just not trying to catch those stray bullets. Need to be on that warning group text
"Stay away today!!"
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
Audit day #5 recap. - this is going to be long as hell, and all over the place. General things I learned are that one - experts can recognize experts - regardless of language barriers. Two - people can hate their job in ANY culture. Three - rude is rude.
It was really Friday the 13th!! Holy shit!!
Started the day with my "homework" (in room #2), bring the information to present. I'm presenting well. They are listening intently. I am almost finished, and they ask...so how exactly does this equipment interface with the computer system?
It doesn't.
They stop and talk amongst themselves and ask - but we specifically want to see how you manage equipment that interfaces with the computerized network. Why would you not bring something like that?
You never requested something that interfaces with the network - you just said any piece of lab equipment in the past 2 years. I brought something from 2 months ago that I was specifically involved with and can speak in depth about it.
Well, yes...but the conversation earlier - we said we wanted that.
I was not in the conversation earlier and you told me you did not want to repeat.
She was like - I am sorry - you are correct and we were unclear. Can you present another piece of equipment that meets these guidelines. And can you do it before 2pm?
Absolutely. So I leave that room.
I get called into another audit room (room #1) to answer some questions. They tell me it is for one system that I'm incredibly familiar with. I get into the room and they hand me a binder for something else. I'm familiar enough - so I start answering with no real issue. I stay there for probably an hour answering question after question after question. My boss walks back in (he was assigned this room - but gets called out into the other rooms often - because we had 3 audit rooms happening simultaneously - which was absolute horseshit. Our site isn't big enough to support this). My boss jumps in and starts trying to bullshit the auditor. It pisses me off - because I KNOW when my boss is trying to bullshit his way through the conversation. Weeeelllll...apparently the auditor understood and picked up on that as well. So the auditor just makes this crazy shift in body language and attitude and demeanor. He starts GRILLING my boss on these very weird technical questions. My boss blushes and can't think of the bullshit fast enough. It's also funny because the interpreters are there - and they translate the insults as well.
I kinda step in here and there and give the logic and rationale and reasons for the "inconsistencies". I explain how the program is structured and how things have improved in the 3 years that I have been here. I have been in industry for ~15 years and traveled from site to site. I told him that the site is 50 years old (we just had out 50th celebration) and explain how equipment is maintained and that things are considered legacy and not updated. It is repaired and maintained until they ultimately crap out and die. I explain how we have this issue and this issue and that we have this in place for reason A B and C. The inspector eventually hits a point where he says that he would like to speak only with me about the equipment and for my boss to not interrupt again (and this is in front of my boss' boss in the room). He asks to see some of the initial paperwork. I told him that it is likely 20 years old and would not be particularly useful or up to today's standards. He said it's fine. We pull the binders and they were 18 years old. He looks at them and chuckles and says something like - well, if you say that you did it - I am satisfied and trust you (I think that pissed my boss off). Afterwards we went back to the original conversation that I was called in for. He was like is this your equipment or my boss'. It was assigned to me for the past 2 years. But it's done randomly so we all get exposure. He was like - show me that last 3 years. I did the past 2 years...my boss did year #3. He goes - I don't need to look at those then and skips my 2 years. We talked about something else that I worked on and closed up some of my loose ends with topics from previous days. He circles back to year #3 (my boss') and starts finding problems with the data and calculations. I get excused from the room.
I leave that room and immediately get called back into room #3. I answer some other questions and they ask am I ready to present the new equipment/homework. I said no - I have been in room #1 for the past 2 hours. They say please don't forget the request. I said no problem
I leave that room and go pull the paperwork that I will need for room #3. I get back into the preparation area (typically called a war room in pharma)...and the people on my research team are like - killa, where have you been? We have a ton of requests that came in - can you start pulling the information? I was flabbergasted. They literally sat in that room for 3 hours and did absolutely nothing. OOOoooooohhhh that shit pissed me off!! There's some specialized info that it would make sense for me to pull. Then there was a ton of general info that they could easily pull...(like training records, calibration records, deviations, and SOPs). Stuff they do every single fucking day in their roles. Oh it pissed me off!! I immediately get called into room #1. So I say - pull the generic stuff - I'll be back for the specialized stuff.
Go into room #1 and answer some questions easily. The interpreter in there told me I talk too fast for her, please slow down. I slow down. Finishe up. Leave room #1 and go to the document center. I see my boss there looking for some document that he can't find. So I help him find it and it is another document that he authored. Someone else approaches and says they are also looking for a document from 2023. It isn't in the document center...but I'm pretty sure my boss is the one who executed, let's check his office. We find it in his office - and it is no where near complete. A document from 2023! Well, the auditor wants to see it as is. So they take it. I go back to the war room and pull like 1 or 2 requests. I walk into doc control and my boss is there. Face all red, and teary eyed. He was talking and was obviously trying not to cry. He kept rubbing his eyes and pinching his nose. He said the inspector said something along the lines of "reviewing his work, he has lost confidence in his ability to lead the dept" or something similar to that effect. Which means he would have said it with my boss' boss in the room (she was the host for that audit room). He's been at the company for like 15/16 years and he is so proud of himself. Specifically for starting at an entry level position and working his way up to a management position. I know my boss isn't popular on site because apparently he has a haughty attitude about him that rubs his former coworkers the wrong way. Anyway...I reassured him that he's only been in the position for 2 months. The problems are much more long running than that...so well identify them, prioritize them, and just fix them one at a time. Plenty of work, and we can take our time to do it right. Easy enough...
It's lunch time. They bought trash for lunch, I wasn't interested. Instead, I take the information for the document to present in room#3 to my desk so I can read in peace. I get to my desk and my contractors are like - I know you're really really busy, but do you have a second to discuss an issue? So we discuss the issue for about 30 mins (of my 1 hour lunch) then I get a text from my boss. They are looking for this document immediately after lunch - is it on the other guy's desk? It is but he's working on it...so it's not organized. They want to see it immediately after lunch, can you compile the info? Ok, sure. So I put it all back in order - which shows me my coworker is a psychopath. And now there's the other 30 minutes of my study time. Lunch time is over and I still haven't reviewed the data. FUCK!
Carry everything back over to the main building. I get messages from all three rooms. The 3 auditors want to speak with you (specifically) immediately after lunch. I explain I'm wanted in all 3 rooms at the same time. So they send me to room #2 first. The interpreter tells me to slow down or she will have to ask me to repeat the answer. I slow down. But the interpreter hates her job. She was soooo fucking rude. She lets out this HUGE, exasperated/frustrated sigh and tells me I am talking too much - just answer with yes or no. I chuckle - because it was so crazy unprofessional. So she stops and is like - I don't think anything about this is funny. Especially not at this point. All of us kinda look at each other in the room and think wtf? The auditor asks more questions and the interpreter tells me "Do not speak, just show me in the information binder". I would point to the things needed and they would read it...and ask me for clarification. At the end, she verbatim said "You are excused and can leave now".
From there I get called back into room #1. Answer some more questions about stuff I'm involved in. It was pretty easy at this point because I built rapport with the auditor here somehow. Leave there and now have to present my homework to room #2. When I walk into room #2. The auditor is talking with the manager in the room and teh shipping SME about shipping stuff. No idea. The manager and teh shipping guy get into an argument right in front of the auditor. The auditor is like we can move on - but the manager says no - we will call the shipping director and get an answer to this right now. The auditor says no thank you - but the manager won't let it go. So teh shipping guy says we can move on - and the two start arguing again about who is right. It was sooooo fucking weird. Anyway - my turn to present (and it was the end of the day. So it worked in my favor because I couldn't speak in depth to the equipment - because I literally never had a second to look at the information). I presented as best I could. I got the impression that the auditor was not an expert in the subject either because she asked the most basic questions. Didn't hurt my feelings. She was ultimately satisfied and we ended the interview.
At the end of an audit - they usually present their initiial findings - and then aboutr a week or so later, you will get an official letter of observations/findings. My dumbass boss said something like - 11 findings...but nothing major, and none related to our department. I was flabbergasted again. I KNOW the big things that they found in passing. I also KNOW that at least two of them are gonna have his name on it. He said something along the lines of being more prepared for next time.
We have an internal meeting to discuss some stuff, so now it's 5:56pm. My brain is fried at this point and I'm ready to go home. BAM! an URGENT!!!!! email comes in at 5:58pm about my other project team. We have this issue, can we meet at 630p to discuss? No - I'm heading over now; everyone else, show up at 6:15p. We talk for about another hour about the project and a path forward. So they say they can write it up tonight and we approve tonight. I said no. Write it up - we will approve Monday morning - the deviation approvals don't have a time stamp - we just need the correct date.
Pack up my shit and start to drive home. I live 25ish minutes away from work...but of course a wreck or car fire on the highway - so craaaaaazy traffic back up. Of course I get there at the same time as the ambulances and fire trucks. Sooooo get home an hour later. Put the kids to bed, take a shower, and blacked out.
Long ass post - but it was really some weird, Friday the 13th type shit!
It was really Friday the 13th!! Holy shit!!
Started the day with my "homework" (in room #2), bring the information to present. I'm presenting well. They are listening intently. I am almost finished, and they ask...so how exactly does this equipment interface with the computer system?
It doesn't.
They stop and talk amongst themselves and ask - but we specifically want to see how you manage equipment that interfaces with the computerized network. Why would you not bring something like that?
You never requested something that interfaces with the network - you just said any piece of lab equipment in the past 2 years. I brought something from 2 months ago that I was specifically involved with and can speak in depth about it.
Well, yes...but the conversation earlier - we said we wanted that.
I was not in the conversation earlier and you told me you did not want to repeat.
She was like - I am sorry - you are correct and we were unclear. Can you present another piece of equipment that meets these guidelines. And can you do it before 2pm?
Absolutely. So I leave that room.
I get called into another audit room (room #1) to answer some questions. They tell me it is for one system that I'm incredibly familiar with. I get into the room and they hand me a binder for something else. I'm familiar enough - so I start answering with no real issue. I stay there for probably an hour answering question after question after question. My boss walks back in (he was assigned this room - but gets called out into the other rooms often - because we had 3 audit rooms happening simultaneously - which was absolute horseshit. Our site isn't big enough to support this). My boss jumps in and starts trying to bullshit the auditor. It pisses me off - because I KNOW when my boss is trying to bullshit his way through the conversation. Weeeelllll...apparently the auditor understood and picked up on that as well. So the auditor just makes this crazy shift in body language and attitude and demeanor. He starts GRILLING my boss on these very weird technical questions. My boss blushes and can't think of the bullshit fast enough. It's also funny because the interpreters are there - and they translate the insults as well.
I kinda step in here and there and give the logic and rationale and reasons for the "inconsistencies". I explain how the program is structured and how things have improved in the 3 years that I have been here. I have been in industry for ~15 years and traveled from site to site. I told him that the site is 50 years old (we just had out 50th celebration) and explain how equipment is maintained and that things are considered legacy and not updated. It is repaired and maintained until they ultimately crap out and die. I explain how we have this issue and this issue and that we have this in place for reason A B and C. The inspector eventually hits a point where he says that he would like to speak only with me about the equipment and for my boss to not interrupt again (and this is in front of my boss' boss in the room). He asks to see some of the initial paperwork. I told him that it is likely 20 years old and would not be particularly useful or up to today's standards. He said it's fine. We pull the binders and they were 18 years old. He looks at them and chuckles and says something like - well, if you say that you did it - I am satisfied and trust you (I think that pissed my boss off). Afterwards we went back to the original conversation that I was called in for. He was like is this your equipment or my boss'. It was assigned to me for the past 2 years. But it's done randomly so we all get exposure. He was like - show me that last 3 years. I did the past 2 years...my boss did year #3. He goes - I don't need to look at those then and skips my 2 years. We talked about something else that I worked on and closed up some of my loose ends with topics from previous days. He circles back to year #3 (my boss') and starts finding problems with the data and calculations. I get excused from the room.
I leave that room and immediately get called back into room #3. I answer some other questions and they ask am I ready to present the new equipment/homework. I said no - I have been in room #1 for the past 2 hours. They say please don't forget the request. I said no problem
I leave that room and go pull the paperwork that I will need for room #3. I get back into the preparation area (typically called a war room in pharma)...and the people on my research team are like - killa, where have you been? We have a ton of requests that came in - can you start pulling the information? I was flabbergasted. They literally sat in that room for 3 hours and did absolutely nothing. OOOoooooohhhh that shit pissed me off!! There's some specialized info that it would make sense for me to pull. Then there was a ton of general info that they could easily pull...(like training records, calibration records, deviations, and SOPs). Stuff they do every single fucking day in their roles. Oh it pissed me off!! I immediately get called into room #1. So I say - pull the generic stuff - I'll be back for the specialized stuff.
Go into room #1 and answer some questions easily. The interpreter in there told me I talk too fast for her, please slow down. I slow down. Finishe up. Leave room #1 and go to the document center. I see my boss there looking for some document that he can't find. So I help him find it and it is another document that he authored. Someone else approaches and says they are also looking for a document from 2023. It isn't in the document center...but I'm pretty sure my boss is the one who executed, let's check his office. We find it in his office - and it is no where near complete. A document from 2023! Well, the auditor wants to see it as is. So they take it. I go back to the war room and pull like 1 or 2 requests. I walk into doc control and my boss is there. Face all red, and teary eyed. He was talking and was obviously trying not to cry. He kept rubbing his eyes and pinching his nose. He said the inspector said something along the lines of "reviewing his work, he has lost confidence in his ability to lead the dept" or something similar to that effect. Which means he would have said it with my boss' boss in the room (she was the host for that audit room). He's been at the company for like 15/16 years and he is so proud of himself. Specifically for starting at an entry level position and working his way up to a management position. I know my boss isn't popular on site because apparently he has a haughty attitude about him that rubs his former coworkers the wrong way. Anyway...I reassured him that he's only been in the position for 2 months. The problems are much more long running than that...so well identify them, prioritize them, and just fix them one at a time. Plenty of work, and we can take our time to do it right. Easy enough...
It's lunch time. They bought trash for lunch, I wasn't interested. Instead, I take the information for the document to present in room#3 to my desk so I can read in peace. I get to my desk and my contractors are like - I know you're really really busy, but do you have a second to discuss an issue? So we discuss the issue for about 30 mins (of my 1 hour lunch) then I get a text from my boss. They are looking for this document immediately after lunch - is it on the other guy's desk? It is but he's working on it...so it's not organized. They want to see it immediately after lunch, can you compile the info? Ok, sure. So I put it all back in order - which shows me my coworker is a psychopath. And now there's the other 30 minutes of my study time. Lunch time is over and I still haven't reviewed the data. FUCK!
Carry everything back over to the main building. I get messages from all three rooms. The 3 auditors want to speak with you (specifically) immediately after lunch. I explain I'm wanted in all 3 rooms at the same time. So they send me to room #2 first. The interpreter tells me to slow down or she will have to ask me to repeat the answer. I slow down. But the interpreter hates her job. She was soooo fucking rude. She lets out this HUGE, exasperated/frustrated sigh and tells me I am talking too much - just answer with yes or no. I chuckle - because it was so crazy unprofessional. So she stops and is like - I don't think anything about this is funny. Especially not at this point. All of us kinda look at each other in the room and think wtf? The auditor asks more questions and the interpreter tells me "Do not speak, just show me in the information binder". I would point to the things needed and they would read it...and ask me for clarification. At the end, she verbatim said "You are excused and can leave now".
From there I get called back into room #1. Answer some more questions about stuff I'm involved in. It was pretty easy at this point because I built rapport with the auditor here somehow. Leave there and now have to present my homework to room #2. When I walk into room #2. The auditor is talking with the manager in the room and teh shipping SME about shipping stuff. No idea. The manager and teh shipping guy get into an argument right in front of the auditor. The auditor is like we can move on - but the manager says no - we will call the shipping director and get an answer to this right now. The auditor says no thank you - but the manager won't let it go. So teh shipping guy says we can move on - and the two start arguing again about who is right. It was sooooo fucking weird. Anyway - my turn to present (and it was the end of the day. So it worked in my favor because I couldn't speak in depth to the equipment - because I literally never had a second to look at the information). I presented as best I could. I got the impression that the auditor was not an expert in the subject either because she asked the most basic questions. Didn't hurt my feelings. She was ultimately satisfied and we ended the interview.
At the end of an audit - they usually present their initiial findings - and then aboutr a week or so later, you will get an official letter of observations/findings. My dumbass boss said something like - 11 findings...but nothing major, and none related to our department. I was flabbergasted again. I KNOW the big things that they found in passing. I also KNOW that at least two of them are gonna have his name on it. He said something along the lines of being more prepared for next time.
We have an internal meeting to discuss some stuff, so now it's 5:56pm. My brain is fried at this point and I'm ready to go home. BAM! an URGENT!!!!! email comes in at 5:58pm about my other project team. We have this issue, can we meet at 630p to discuss? No - I'm heading over now; everyone else, show up at 6:15p. We talk for about another hour about the project and a path forward. So they say they can write it up tonight and we approve tonight. I said no. Write it up - we will approve Monday morning - the deviation approvals don't have a time stamp - we just need the correct date.
Pack up my shit and start to drive home. I live 25ish minutes away from work...but of course a wreck or car fire on the highway - so craaaaaazy traffic back up. Of course I get there at the same time as the ambulances and fire trucks. Sooooo get home an hour later. Put the kids to bed, take a shower, and blacked out.
Long ass post - but it was really some weird, Friday the 13th type shit!
Re: There we go
Damn homie! After reading that the first thing that comes to mind is you'll be first in line for a promotion and how long will your manager have his job for?
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
They wanted me to apply for that manager position. I passed it by. Before the audit, several managers wanted to confirm that I was involved. They said they wanted me to speak with the auditors moreso than my boss [off the record of course].
I said I have no problem speaking with them..but in reality: #1 - I have no interest in climbing the ladder. #2 - I KNOW what is wrong with the company/site/department. I can compare this $50MM site to plenty of other, multi BILLION dollar sites that I've been at before. I enjoy my small, slow paced, low stress, generic facility. I need nothing that is cutting edge/state of the art. I don't want responsibility. I don't want to manage people. The way it is right now - I do what I want when and how. I come in at 8a, I leave at 2/2:30p. I take an hour lunch. I work 4 days a week. I still collect a full salary and bonus. And the work is EASY!! No one says shit to me because any- and every- thing that is assigned to me is ALWAYS completed early or on time. Plus the quality of my work is top notch (which isn't to say that I don't make mistakes). Technically, I am the only one in the department that has an actual title that matches my responsibilities. I am a Sr Process Validation Engineer. Everyone else has the title of Sr Validation Engineer, Validation Engineer 1 2 and 3. So I do the Process Val stuff (I have 3 right now), plus projects (I have 3 right now), plus validation maintenance stuff (everyone gets like 10 per year). I actually do the most in the dept. The others only have 2 projects between them and maybe 4 pieces of equipment to bring online (assigned to the younger guys and me and Ms Thickums provide guidance). I look at it and say - I could do five of them in 1 month. But instead, most of them are behind schedule. Every so often, I'll take on something for Ms Thickums to pull her along and catch her up. She tells me all the time that most people aren't like me and can't be introduced to something...and then understand it entirely in under 2 weeks, in passing, without having someone explain everything. I said that's not true at all (but my wife says the same thing all the time. About if she only had my brain and her work ethic (though I have a much stronger work ethic than my wife)).
Anyway, I'm already at the top of the pay scale - so I get like a 0.5% pay bumps, but they maximize my bonuses to try to compensate (starts at 5% but I've gotten 9% and 10% the last 2 years). I'm already rich, so the money isn't a big driver for me. (My wife took on a management role at her company. Came with a $20-$30k pay bump, I don't remember - but I have to listen to her complain about the people who work for her daily. I hate it.) I'm respected. Some of the projects I've worked on had so much visibility, I'm known by so many people at the site leadership and corporate level (I particularly enjoy when the French colleagues from corporate come and put a nigga's face to the name and work. They are always like... Are you uh killa? Zzee SME on zee uh ___ prohject? *but of course in a French accent - it has a certain cadence * I don't know french political correctness, but they never expect a black guy. And you can see it all over their face. * I'm liked by almost everyone at the site. I'm trusted (which is the weird one to me - because I don't like most people, but they don't seem to notice. But people tell me all the gossip, all the drama, all the issues, all the secrets. It's always been like that in life).
All of that is to say - I plan to stay here for as long as possible or until something drastically changes. Our biggest change is the new boss. He likes to focus on teh dumbest things -but that's his right. I honestly don't care what happens at work. I tell people all the time. You can be stressed out, you can be pissed, you can be happy, or sad. It doesn't really matter - it all pays the same.
On the production floor, I will do the highly skilled labor involved in my job. But I'll break out the pallet jack and move some racks around. It doesn't matter to me - it all pays the same.
I said I have no problem speaking with them..but in reality: #1 - I have no interest in climbing the ladder. #2 - I KNOW what is wrong with the company/site/department. I can compare this $50MM site to plenty of other, multi BILLION dollar sites that I've been at before. I enjoy my small, slow paced, low stress, generic facility. I need nothing that is cutting edge/state of the art. I don't want responsibility. I don't want to manage people. The way it is right now - I do what I want when and how. I come in at 8a, I leave at 2/2:30p. I take an hour lunch. I work 4 days a week. I still collect a full salary and bonus. And the work is EASY!! No one says shit to me because any- and every- thing that is assigned to me is ALWAYS completed early or on time. Plus the quality of my work is top notch (which isn't to say that I don't make mistakes). Technically, I am the only one in the department that has an actual title that matches my responsibilities. I am a Sr Process Validation Engineer. Everyone else has the title of Sr Validation Engineer, Validation Engineer 1 2 and 3. So I do the Process Val stuff (I have 3 right now), plus projects (I have 3 right now), plus validation maintenance stuff (everyone gets like 10 per year). I actually do the most in the dept. The others only have 2 projects between them and maybe 4 pieces of equipment to bring online (assigned to the younger guys and me and Ms Thickums provide guidance). I look at it and say - I could do five of them in 1 month. But instead, most of them are behind schedule. Every so often, I'll take on something for Ms Thickums to pull her along and catch her up. She tells me all the time that most people aren't like me and can't be introduced to something...and then understand it entirely in under 2 weeks, in passing, without having someone explain everything. I said that's not true at all (but my wife says the same thing all the time. About if she only had my brain and her work ethic (though I have a much stronger work ethic than my wife)).
Anyway, I'm already at the top of the pay scale - so I get like a 0.5% pay bumps, but they maximize my bonuses to try to compensate (starts at 5% but I've gotten 9% and 10% the last 2 years). I'm already rich, so the money isn't a big driver for me. (My wife took on a management role at her company. Came with a $20-$30k pay bump, I don't remember - but I have to listen to her complain about the people who work for her daily. I hate it.) I'm respected. Some of the projects I've worked on had so much visibility, I'm known by so many people at the site leadership and corporate level (I particularly enjoy when the French colleagues from corporate come and put a nigga's face to the name and work. They are always like... Are you uh killa? Zzee SME on zee uh ___ prohject? *but of course in a French accent - it has a certain cadence * I don't know french political correctness, but they never expect a black guy. And you can see it all over their face. * I'm liked by almost everyone at the site. I'm trusted (which is the weird one to me - because I don't like most people, but they don't seem to notice. But people tell me all the gossip, all the drama, all the issues, all the secrets. It's always been like that in life).
All of that is to say - I plan to stay here for as long as possible or until something drastically changes. Our biggest change is the new boss. He likes to focus on teh dumbest things -but that's his right. I honestly don't care what happens at work. I tell people all the time. You can be stressed out, you can be pissed, you can be happy, or sad. It doesn't really matter - it all pays the same.
On the production floor, I will do the highly skilled labor involved in my job. But I'll break out the pallet jack and move some racks around. It doesn't matter to me - it all pays the same.
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xandorxerxes
- Posts: 807
- Joined: Mon Nov 18, 2019 12:43 pm
Re: There we go
As someone who both is in and performs a lot of audits... What a cluster.
Re: There we go
hopefully the rest of the audits go well!
Re: There we go
Had to tell the wifey that not wanting me to watch Dragon Ball with my son is a red line. I agree with some of the shows, but Dragon Ball, especially Daima is not that serious. Before that I told her Daima and Sonic 3 are practically rated the same. She did not like to hear that lol. She's okay not to cross the Dragon Ball line lol.
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killacross
- Posts: 1900
- Joined: Mon Nov 18, 2019 7:00 am
- Location: NC, USA
Re: There we go
So you think everything can be solved by punching someone in the mouth if they have a disagreement?
Naaaaaaaaaw dawg... Gotta side with the wifey here. Toriyama was literally Hitler.
Naaaaaaaaaw dawg... Gotta side with the wifey here. Toriyama was literally Hitler.