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Sundae posted:"Hmm... temperature's a little high this week. Heat wave. Eh, we can still run batches. We're a huge facility with an enormous HVAC system, so there shouldn't be--" was there a common root cause?
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Jun 14, 2019 15:05
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quote:was there a common root cause? Murphy and hubris. They didn't do an investigation for it. This tells me that the root cause is "not treating GMP facility systems like the impact-critical units they are."
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Jun 14, 2019 20:44
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I want to learn GMPs for the FDA regulated sectors I want to work in (not that I'd be doing GMP work); people treat them as complex, but the stuff I find in documentation is all mind-numbingly straightforward.
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Jun 18, 2019 20:33
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Discendo Vox posted:I want to learn GMPs for the FDA regulated sectors I want to work in (not that I'd be doing GMP work); people treat them as complex, but the stuff I find in documentation is all mind-numbingly straightforward.
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Jun 18, 2019 20:42
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Discendo Vox posted:I want to learn GMPs for the FDA regulated sectors I want to work in (not that I'd be doing GMP work); people treat them as complex, but the stuff I find in documentation is all mind-numbingly straightforward. For every mind-numbingly straightforward regulation in the field that I can't imagine we actually need, I end up finding a mind-numbingly stupid person who justifies the requirement. GMP stuff is very easy to understand, very straightforward, and apparently unbelievably hard for some people to wrap their heads around. The only area I think is a little tough at times is 21 CFR Part 11, and even then it's only because closed-source software/hardware vendors really don't like it when you ask to look under the hood. Everything else is just trying to stay ahead of weaponized best practices from other companies and juggling conflicting FDA & Board of Director priorities. While not the worst thing I've heard, one of the most annoying recurring things is for someone to argue that "nothing in (procedure or batch record) says I can't do ________." No, you dumb fucker, that's not how that works. Nothing in the batch record says you can't pick your nose and wipe it into the dispensed raw materials either, but somehow we all understand that you still can't do that. Sundae fucked around with this message at 04:16 on Jun 19, 2019 |
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Jun 19, 2019 04:12
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GMP at a high level is very straight forward to read and understand conceptually, but can be pretty vague, especially in the clinical space. This gives you plenty of room to get into arguements over specifics of how you decide to implement them. Even more fun when your quality unit is really conservative, but your working with an external vendor that's more lax, but technically complaint.
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Jun 19, 2019 11:29
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Okay, great, these answers help me confirm there isn't some annex to the law that I'm missing that's full of, like, product-specific per step contaminant thresholds and temperature standards.
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Jun 19, 2019 16:58
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Beating a dead horse but GMP isn’t hard when done right, as long as personnel can follow procedure and the procedure isn’t terrible it works quite well. Of course if quality unit is brain dead and can’t seem to comprehend what the intent of the procedure is it loving sucks. Our QA interpreted the only “one admin for a computer “ as “one admin for the computers”. And our admin is in the hospital after a particularly nasty car crash with a drunk driver, QA lost the envelope with the passwords so now we can’t even calibrate half the stuff in the lab until this guy is back to work.
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Jun 19, 2019 19:03
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Discendo Vox posted:Okay, great, these answers help me confirm there isn't some annex to the law that I'm missing that's full of, like, product-specific per step contaminant thresholds and temperature standards. Those still exist in some cases, but they're more of a gray area. For example, GMP guidelines will say that your manufacturing plant needs to maintain adequate air purity levels and temperature control / monitoring to ensure quality production. These are expected to be documented somewhere. However, it doesn't tell you precisely what they mean by "adequate" in many cases. Other standards or laws will exist, so you end up building to those guidelines and then your qualification document says that you built the facility processing rooms to ISO Class E air standards. Then the auditor says "Oh, Class E? That requires you keep your total particulate counts to below ____________ and that you maintain an ongoing monitoring program. Please show me your environmental monitoring reports for the last two years and any investigations you initiated for environmental monitoring excursions." The fact that it's not in 21CFR quite so explicitly actually creates a bit of a problem sometimes, because it's not actually "GMP" but "cGMP" that you end up worrying about. Your practices were GMP last audit, or five audits ago, or whatever. Are they the current best practices? Well, this auditor just came from (e.g.) Novartis' new facility where they had an ongoing continuous monitoring program that keeps a 24/7 track on particulate levels while you're only checking every two months with a stratified sampling process. Are you sure you're doing the best you can? Auditor thinks you can be doing better. You get a finding because you aren't meeting what the rest of the industry (or really just Novartis) is doing. It's not a critical finding but now you need an action plan and they're coming back in 12 months to see the new program implementation. That's where the weaponized best practices thing in my post came in. While no company wants to deal with any more regulation than they have to, every now and then I've worked somewhere that had a system they managed to work out that was really, really good at what it did. So, they'd actually try to push it as a standard approach so that the rest of the industry would get slammed with it and have to play catch-up to get back into compliance. It's not a common thing, but it happens. You also never know when you're going to just get a loving idiot auditor. I had one at my last place who wanted 100% inspection for weight, hardness, thickness and in-line potency reading on a press producing 250,000 tablets per hour. He decided that sampling plans and release testing just weren't good enough anymore and we needed to do better. His finding was overruled by the lead auditor and didn't show up in the final report, but we had a great few weeks of intense worrying / calling every other industry contact we had to find out if they were getting hit with that poo poo too, while we waited for the final report. We called him Chuckles the Audit Clown behind his back because (1) he was a weirdo idiot and (2) he walked around the entire loving day without realizing his steel-toed shoes were on the wrong feet.
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Jun 19, 2019 19:57
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I need to dig into how FDA handles auditing- I've heard a couple of these stories at this point and they cut against the general impression of FDA as highly competent but completely starved of all resources past all common sense.
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Jun 19, 2019 21:52
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Sundae posted:Those still exist in some cases, but they're more of a gray area. For example, GMP guidelines will say that your manufacturing plant needs to maintain adequate air purity levels and temperature control / monitoring to ensure quality production. These are expected to be documented somewhere. However, it doesn't tell you precisely what they mean by "adequate" in many cases. God forbid you're in an industry that is both federally regulated and individually regulated state-to-state. Most states are too underfunded to regulate effectively, so they punt to the industry leaders. This is mostly fine, if the industry leaders are mostly benevolent. Fortunately they mostly are in my industry. I've posted enough poo poo in this thread that I can be personally identified, so I can't name and shame. But some state regulators try to wing it and are a pain in the rear end because they honestly have no clue what they're doing. But they think they should be regulating stuff, so they just make rules arbitrarily. Places like California that regulate more than other states aren't really a problem. They are sophisticated and well-funded enough to make sensible, if heavy-handed at times, regulations and enforce them fairly. It's the places that make arbitrary regulations and don't enforce them that are the problem. It's a real problem if you're acting above-board and someone else is cheating and winning all the contracts because of it.
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Jun 20, 2019 00:15
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Sundae posted:he walked around the entire loving day without realizing his steel-toed shoes were on the wrong feet. I can't wrap my mind around how this could happen to a human adult competent to dress themselves
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Jun 20, 2019 00:41
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Sundae posted:Chuckles the Audit Clown Our customer auditors are either amazing or loving open mouths like chuckles, of course our QA is also open mouth so we would end up having to breakdown every tablet and test them, all 250k of them.
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Jun 20, 2019 03:05
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CA food labeling law is nuts. CA in general is nuts. loving voter items. Spend a few million and you can basically get any law you want on the books.
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Jun 20, 2019 14:56
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Discendo Vox posted:I need to dig into how FDA handles auditing- I've heard a couple of these stories at this point and they cut against the general impression of FDA as highly competent but completely starved of all resources past all common sense. I started writing a post responding to this but the workday ended and I went home.  I think the "starved of resources" part is where things start to get ugly, honestly. Let's just take a quick example, pulled from USAJobs...  That GS-7 job there will pay 50-100% more if you go into industry, depending on location. That GS-15 role is a PhD+Lots of Experience+Management Experience that will both pay 50-100% more than that in industry and which also is capped at the top of the general schedule and cannot go any higher without exiting the general scale entirely. The epidemiologist will say "wtf" and double or triple his pay in the private sector. It's not all brain drain, but "desire to do good things" only goes so far before bureaucratic nightmares and paperwork make you reconsider whether cashing a fat check is preferable to poor pay plus constant roadblocks to doing anything productive. Industry will hire away anyone competent that they can sway to join them, leaving behind idealistic youngsters, jaded and cynical middle-career people, and whoever they can get to fill the seat that is even remotely qualified. Director-level people are apparently a different mixed bag because while often highly-qualified individuals, it's so hard to jump from GS ladder to E ladder that pretty much any qualified candidate gets pulled from industry leadership anyway, creating the revolving door we all know and hate. Maybe you get someone qualified and well-meaning to do the job, but given E ladder pay is even more pathetic compared to industry-equivalent compensation, it's more likely that you get someone who fixes a few "inefficiencies" and then heads back to a cushy job making five times as much.
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Jun 20, 2019 18:13
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Got my second-round interview for that field service position lined up for Tuesday  The HR person said it would be to gauge my technical background, but in looking up the person who I'll be speaking with they don't have a chemistry background like I was expecting, they've just been working in instrument field service for a long-rear end time (also they have an MBA for some reason?). What types of questions do you think I should expect from a technical interview for this type of role- is it more about understanding the science of what the instruments are doing, or more of understanding how the different components of an instrument interact with one another?
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Jun 22, 2019 23:52
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C-Euro posted:Got my second-round interview for that field service position lined up for Tuesday Edit: They want to hire someone who knows more than them technically. So don't be shy about showing off your knowledge.
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Jun 23, 2019 02:27
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Update: first question he asked me was "how do you change a tire?", which I know the basics of but haven't had to do in several years, so I spent the rest of the interview with "why the gently caress did he ask that" in the back of my mind. I did say I'd look at the owner's manual though, which seems like a good policy to have for instrument service but maybe not the one he wanted. I don't think I'm getting a callback.
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Jun 25, 2019 22:14
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Unless your new job actually required changing tires, I'm not sure you wanted to work with that guy anyway. That's an rear end in a top hat question for rear end in a top hat interviewers.
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Jun 25, 2019 22:25
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C-Euro posted:Update: first question he asked me was "how do you change a tire?", which I know the basics of but haven't had to do in several years, so I spent the rest of the interview with "why the gently caress did he ask that" in the back of my mind. I did say I'd look at the owner's manual though, which seems like a good policy to have for instrument service but maybe not the one he wanted.
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Jun 25, 2019 22:46
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Dik Hz posted:He was probably looking for how you describe a technical process and that's the most technical process he knows/thinks everyone should know. Also looking for people that are "handy". Could just be that they had one FSE that got a flat and couldn't change it and their customer's instrument was down for an extra day. Who knows. May not be the end of the world though. Looking at the manual is a safe enough answer (assuming they have one for their instruments). Some people would rather teach the science to tinkerers/handy folks than the other way around though and it could have been a proxy to gauge how you'd handle swapping a PCB behind four other components. If you thought the rest of it went fine you'll probably get a call back.
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Jun 25, 2019 23:04
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I think the more damning thing was how bored he sounded during the whole interview, though he would be my boss's boss if I get hired and I think he was tapped at the last minute to do this interview. More damning still is that he claimed the service area was more than double the size that the HR person gave me during my first call, and definitely fits the "4-5 days on the road, 2-3 nights in hotels" that was on the job description. And obviously I trust the manager doing the work to give me a better estimate more than the HR person who's just trying to put a butt into a seat. That's not the kind of travel I want when my wife and I are hoping to start a family (and when she already works somewhat sporadic hours). Oh well, time to take what I learned and apply it to the next opportunity.
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Jun 26, 2019 01:15
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C-Euro posted:I think the more damning thing was how bored he sounded during the whole interview, though he would be my boss's boss if I get hired and I think he was tapped at the last minute to do this interview. More damning still is that he claimed the service area was more than double the size that the HR person gave me during my first call, and definitely fits the "4-5 days on the road, 2-3 nights in hotels" that was on the job description. And obviously I trust the manager doing the work to give me a better estimate more than the HR person who's just trying to put a butt into a seat. That's not the kind of travel I want when my wife and I are hoping to start a family (and when she already works somewhat sporadic hours). Oh well, time to take what I learned and apply it to the next opportunity. This is a good attitude to have about it. A job interview is a chance for you to learn if a job is a good fit for you as much as it is for you to prove yourself, and it sounds like this place isn't where you want to be.
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Jun 26, 2019 01:44
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My boss's boss's rear end in a top hat question is asking you if you know how a toilet works, then telling you to describe the actual mechanism if you say yes. I told him it was a dirty trick because if you ask two fluid dynamicists how a siphon works you'll get three answers.
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Jun 26, 2019 02:22
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I was a great FSE and I don't change tires. I take my car in for regular maintenance and let someone who knows about cars work on it. If I have a blow out I call AAA. If they asked me how to change a tire I would have had a really dumb answer lmao. That's annoying as hell that they won't give you a realistic/accurate idea of how much travel there is, but that tends to be common.
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Jun 26, 2019 10:35
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Correct answer: I'd have to check the manual. I keep up on my preventative maintenance so I've yet to have ant tires fail on me.
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Jun 26, 2019 11:11
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Just ask the interviewer how long it’s been since they checked the tire pressure in their spare 
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Jun 26, 2019 15:34
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Career progression question: Currently work as a "Liquid Handling Automation Specialist" but my title is Senior RA. Have a masters in bioengineering and do a lot of genetics work right now. My role currently involves programming with the Hamilton Star and running samples through my methods. I did some FSE work prior on some bulk dispensers which is how I got into this. Recently had a mid year review and it's difficult to identify growth opportunities to pursue. I'm the only one here doing this sort of work so there's not much in the way of mentoring opportunities either. I'm doing fine and the boss is happy with what I've got done so far since starting, but I'm starting to get a bit bored now that I've got the bulk of my programming done. I'm not really a part of the actual science that's going on currently, but my group is more along the lines of helping therapeutic areas figure out how to get the data they want anyways. I'm happy to use my free time at work to do personal growth projects but having a hard time coming up with things. I'm not sure what sort of job comes next here but I was going to poke around various postings and identify some skills to work on. Any thoughts? Like I'm happy with my job but just getting bored now that the initial rush of learning a new system is over. I know it's kind of vague but TLDR: have some spare time and want to keep learning new things to prevent being bored, but also want it to be relevant to my current role.
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Jun 27, 2019 15:10
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If anyone is looking for a career move into project management, my group has an opening. We oversee manufacture of clinical API in our external manufacturing network. Would be looking for people with process or analytical chemistry backgrounds mostly. Feel free to shoot me a PM. Position is in NJ.
gninjagnome fucked around with this message at 21:21 on Jun 27, 2019 |
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Jun 27, 2019 21:17
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gninjagnome posted:If anyone is looking for a career move into project management, my group has an opening. We oversee manufacture of clinical API in our external manufacturing network. Would be looking for people with process or analytical chemistry backgrounds mostly. Feel free to shoot me a PM. Position is in NJ.
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Jun 29, 2019 04:41
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Dik Hz posted:Any chance at remote? I'm looking for a process/analytical PM job right now, but I'm geographically constrained by the fact that my partner is a practicing attorney in NC. Polymer experience, not API, though. I'd love to do API. Unfortunately, probably not. Although a lot of the job could be done remotely, since there are a lot of calls/emails with our external manufacturers, you need to work a lot with the technical teams based in NJ. If you had a lot of API experience, I could try to pitch it, but my boss would want a lot of direct mentorship if you didn't have any API experience, so it would be a real hard sell.
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Jun 30, 2019 01:47
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gninjagnome posted:Unfortunately, probably not. Although a lot of the job could be done remotely, since there are a lot of calls/emails with our external manufacturers, you need to work a lot with the technical teams based in NJ. If you had a lot of API experience, I could try to pitch it, but my boss would want a lot of direct mentorship if you didn't have any API experience, so it would be a real hard sell.
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Jun 30, 2019 22:07
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After getting shot down for that field tech/service role last week, we have two field technicians visiting our office today to work on a GC/MS and I can't figure out how to get them alone to pick their brains about their job  The universe is rubbing it in now.
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Jul 1, 2019 18:00
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C-Euro posted:After getting shot down for that field tech/service role last week, we have two field technicians visiting our office today to work on a GC/MS and I can't figure out how to get them alone to pick their brains about their job
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Jul 1, 2019 23:29
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Dik Hz posted:I figured as much. Thanks for the info. Do you have any advice on pitching API people when I only have experience in polymers? It'll really depend on the specific group you're looking at. General project management skills should be transferable across industries, so if you have experience as a PM in different areas, you could talk about how you've been able to do that. If you're looking to move towards an analytical position, emphasize any experience with method qualification and validation. Definitely leverage any experience you have with regulators , even if it's not the FDA, and any experience you have with formal quality systems (ISO, etc.), just to show you have the right mind set.
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Jul 3, 2019 00:49
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gninjagnome posted:It'll really depend on the specific group you're looking at. General project management skills should be transferable across industries, so if you have experience as a PM in different areas, you could talk about how you've been able to do that. If you're looking to move towards an analytical position, emphasize any experience with method qualification and validation. Definitely leverage any experience you have with regulators , even if it's not the FDA, and any experience you have with formal quality systems (ISO, etc.), just to show you have the right mind set.
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Jul 5, 2019 02:41
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We are always hiring LIMS business analysts and project managers. If anyone is interested I can submit resumes. Most of our folks work from home except for when they are traveling.
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Jul 5, 2019 08:33
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I'm looking to hire an analytical chemist with polymer experience. Position is located in the Piedmont Triad area of North Carolina. A fresh grad who took polymer chemistry and the associated lab would be a good fit for the position. Or someone with a chem degree and a couple years in the coatings industry. If anyone here is interested, let me know and I'll give you my contact info. Edit: I do realize I posted that I hate analytical with a passion two posts up. Don't worry, this position doesn't report to me.
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Jul 9, 2019 21:30
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Just had an argument with my boss over buying a cheap hygrometer to put in our new glove box so that we would know when it’s dry enough to use. Her response was we don’t need one because someone would write it down in their notebook and this wouldn’t be calibrated. When I asked how would we know if the box was sufficiently purged with nitrogen to know if it was dry she said we purged it with nitrogen and the O2 meter would tell us when that was done. Since our procedure says to weigh under nitrogen that’s all we have to do. I was on the fence about going back to school to get out of the lab but I’m pretty convinced now.
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Jul 10, 2019 19:02
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Does humidity matter? If not, I'm with your boss on this one.
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Jul 10, 2019 22:01
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