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Sundae posted:The WTFBBQ regulations are by far my favorite set. So how did that FDA audit go?
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May 20, 2015 17:34
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Solkanar512 posted:So how did that FDA audit go? We got a team of people who had never been in a solids pharma facility before. They gave us a few 483s for bullshit that was easily explained, but since they had all biologics experience, they missed all the REAL fruit and just picked up the low-hanging bullshit. Like, we got a 483 for not following our protocol for a validation, but not for a systemic failure we ignored that could have (potentially -- highly unlikely, but we don't know and never checked) implicated somewhere in the vicinity of 5,000 batches. The company got extremely lucky by getting auditors who knew poo poo about gently caress.
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May 20, 2015 17:48
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Sundae posted:We got a team of people who had never been in a solids pharma facility before. They gave us a few 483s for bullshit that was easily explained, but since they had all biologics experience, they missed all the REAL fruit and just picked up the low-hanging bullshit. Like, we got a 483 for not following our protocol for a validation, but not for a systemic failure we ignored that could have (potentially -- highly unlikely, but we don't know and never checked) implicated somewhere in the vicinity of 5,000 batches. Some days I wish I was an auditor, just find something to bitch about and your day is complete.
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May 20, 2015 22:13
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Sundae posted:We got a team of people who had never been in a solids pharma facility before. They gave us a few 483s for bullshit that was easily explained, but since they had all biologics experience, they missed all the REAL fruit and just picked up the low-hanging bullshit. Like, we got a 483 for not following our protocol for a validation, but not for a systemic failure we ignored that could have (potentially -- highly unlikely, but we don't know and never checked) implicated somewhere in the vicinity of 5,000 batches. Well, that's not terrifying or anything. How did this happen, and who was on the audit team?
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May 20, 2015 22:31
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Discendo Vox posted:Well, that's not terrifying or anything. How did this happen, and who was on the audit team? Two biologics guys and a documentation guy. Apparently not one of them had ever been in a solids facility before, so they weren't familiar with the sorts of systems we were using. Instead, they just latched onto the first thing they found/understood.
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May 20, 2015 23:05
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None of this is remotely in my work area, but that really shouldn't be happening-biologics inspections is a whole different office from drugs inspections, has different oversight offices and are governed under an entirely different ruleset (Chapter 5.5 versus 5.7 in the manual), and different CP docs for the details of the inspection. These people should have undergone a separate prep regime and been up to par before they arrived, even for normal compliance inspection. Cripes.
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May 21, 2015 00:25
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Yeah... I got called in during the audit to explain the functionality of a tablet press and what basic components of the press did. At least one of them had never seen a tablet press, which is unbelievable for someone who is supposed to be providing oversight for a solids facility.
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May 21, 2015 00:43
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Sundae posted:Yeah... I got called in during the audit to explain the functionality of a tablet press and what basic components of the press did. At least one of them had never seen a tablet press, which is unbelievable for someone who is supposed to be providing oversight for a solids facility. There are ways to notify the FDA about this sort of thing. The systemic failure you mentioned wouldn't have to be a part of it- you and your firm could remain fully anonymous. I'm less worried about your company than the next ten that team audited- and whatever screwup caused an improperly trained audit team to be in the field in the first place.
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May 21, 2015 02:19
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Could you PM me details about the reporting approach, if you know? I'm all game for doing that.
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May 21, 2015 02:34
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Sundae posted:Could you PM me details about the reporting approach, if you know? I'm all game for doing that. Done and sent. I look forward to seeing your photo in the papers: standing outside a burning factory in Bangladesh, surrounded by men in Hazmat suits holding geiger counters. edit: and rifles, they'll also be holding rifles. Discendo Vox fucked around with this message at 21:49 on May 21, 2015 |
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May 21, 2015 05:41
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Hey Goons, I'm posting on behalf of my girlfriend - she's looking for a new job due to her current one being relocated. She's having trouble finding a lab in our area that doesn't require licensing to work for, I figured maybe you experienced guys have some knowledge of some lab jobs she would not have thought to apply for due to it requiring some out of the box thinking. She has a bachelors of biology from st johns, and is finishing a second bachelors in med tech, and has 4 years of experiencing working in a food QC lab. We're on long island, NY. She's getting pretty desperate because it's getting close to the point where the relocation is happening and she doesn't see many options outside of working a non-lab job which she'd rather not do. Thanks!
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May 21, 2015 16:13
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First off, tell your girlfriend to get her resume done by that guy in SA-Mart. Secondly, she should be looking at QC/QA work in multiple industries. Four years of experience in various cGMP/ISO environments is a huge boon. Focus on that experience with the regulated environment and I think things will go much better. If all else fails, she has a great chance switching industries all together.
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May 21, 2015 16:32
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Good news, your favorite wearable candies are sulfite free. 
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May 21, 2015 19:57
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Long Island goon I don't know how far northern NJ is for your lady to commute but I know there's a lot of food chemistry places in NJ if she wants to stay in that field, particularly flavor chemistry. Miss Ginger posted:What field are you in now? I'm unemployed and borderline homeless  I moved to Philadelphia with my fiancée this week (she got a good job) and am looking for work. I did have a guy call me about doing regulatory and technical documentation work, based off my strong chemistry background and having done some work with our regulatory group at my last job. You just have to be willing to look outside of your comfort zone.
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May 21, 2015 21:18
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Sorry to double-post, but do any of you lab goons work non-first shift hours? I'm applying for lab work and seeing quite a few positions with second or third shift hours. In particular, I just got an email from a guy about a QC position that goes 7 PM to 7 AM three days a week with a fourth day every other week, which sounds miserable (especially since I would never see my fiancée) and I feel like an MS makes me overqualified for night shifts. At the same time I'm not sure how picky I can be right now and it's only a six-month contract position so I have an out if I don't like it. I'll respond anyway but I'm curious to hear if any of you work hours like that.
C-Euro fucked around with this message at 14:18 on May 22, 2015 |
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May 22, 2015 14:15
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C-Euro posted:Sorry to double-post, but do any of you lab goons work non-first shift hours? I'm applying for lab work and seeing quite a few positions with second or third shift hours. In particular, I just got an email from a guy about a QC position that goes 7 PM to 7 AM three days a week with a fourth day every other week, which sounds miserable (especially since I would never see my fiancée) and I feel like an MS makes me overqualified for night shifts. At the same time I'm not sure how picky I can be right now and it's only a six-month contract position so I have an out Just if I don't like it. I'll respond anyway but I'm curious to hear if any of you work hours like that. I did a 6 month rotation that was rotating shift, one weeks day, one week nights early. Our shifts were ~ 7 am - 3 pm, and 3 pm - 11 pm though. It wasn't too bad, you could schedule appointments get stuff done in the morning. I'd still avoid doing it full time if I could though. 7-7 would probably be a lot worse. From a level perspective, are you managing other people? Some of our analytical shift supervisors have masters, and the head of the group has a PhD (and sometimes covers nights).
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May 22, 2015 15:07
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Nah I'm reporting to a supervisor. Alternating weeks of first and second shift actually doesn't sound too bad though, but I haven't seen any of those.
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May 22, 2015 21:49
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I'm just finishing up a Ph.D. and just got a nice-looking job offer for research at a biotech startup (~30 employees). Everything's looking good, but on the offer the one red flag I noticed was complete transfer of intellectual property rights to the company. Is that sort of clause standard for industry or is it negotiable?
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May 22, 2015 22:59
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Stan Lee Jeans posted:I'm just finishing up a Ph.D. and just got a nice-looking job offer for research at a biotech startup (~30 employees). Everything's looking good, but on the offer the one red flag I noticed was complete transfer of intellectual property rights to the company. Is that sort of clause standard for industry or is it negotiable?
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May 22, 2015 23:03
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Stan Lee Jeans posted:I'm just finishing up a Ph.D. and just got a nice-looking job offer for research at a biotech startup (~30 employees). Everything's looking good, but on the offer the one red flag I noticed was complete transfer of intellectual property rights to the company. Is that sort of clause standard for industry or is it negotiable? Dik Hz posted:That clause is standard across all of R&D everywhere. No matter how it's written, the courts have protected your rights to your own IP that is unrelated to your work. So it's not like they can just claim anything you invent off hours if it doesn't relate to the business. Please note IANAL, though. Normally I'm one for negotiating everything always, but I wouldn't recommend negotiating in this case. IANAL as well, but be aware that the standard I've frequently encountered is if you use pretty much even the slightest amount of on--the-clock time, or company resources, in inventing the thing, they may be able to claim it. Sometimes conceptual similarity can be enough for them to make it seem like you were developing it on their time-it varies. That said, it's also a policy of pretty much every research university, too- it really is close to boilerplate for entities that do research. If they didn't have something along those lines, you could claim ownership of your work product, and potentially even sell it to competitors.
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May 23, 2015 00:14
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Stan Lee Jeans posted:I'm just finishing up a Ph.D. and just got a nice-looking job offer for research at a biotech startup (~30 employees). Everything's looking good, but on the offer the one red flag I noticed was complete transfer of intellectual property rights to the company. Is that sort of clause standard for industry or is it negotiable? Also IANAL but this sound pretty standard for all the friends I have in industry jobs.
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May 23, 2015 00:31
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Stan Lee Jeans posted:I'm just finishing up a Ph.D. and just got a nice-looking job offer for research at a biotech startup (~30 employees). Everything's looking good, but on the offer the one red flag I noticed was complete transfer of intellectual property rights to the company. Is that sort of clause standard for industry or is it negotiable? Goongratulations. That's standard for every industry job.
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May 23, 2015 04:02
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Discendo Vox posted:IANAL as well, but be aware that the standard I've frequently encountered is if you use pretty much even the slightest amount of on--the-clock time, or company resources, in inventing the thing, they may be able to claim it. Sometimes conceptual similarity can be enough for them to make it seem like you were developing it on their time-it varies.
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May 23, 2015 19:53
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I always wondered why they bothered with those clauses, but then we had to fire a guy that actually independently filed (and received!) a patent for work he did on at my company. He got caught when legal did a patent search as part of the due diligence work as we were getting ready to apply for a our own patent,. Apparently he was trying to start a consulting, and was going to say he was a paid consultant at my company, and his work resulted in the patent. Not sure how he thought he'd get away with it.
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May 24, 2015 01:01
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gninjagnome posted:I always wondered why they bothered with those clauses, but then we had to fire a guy that actually independently filed (and received!) a patent for work he did on at my company. He got caught when legal did a patent search as part of the due diligence work as we were getting ready to apply for a our own patent,. Apparently he was trying to start a consulting, and was going to say he was a paid consultant at my company, and his work resulted in the patent. Not sure how he thought he'd get away with it. It's a common issue when someone who's been involved with the creation of a thing realizes how much the creation is worth- there's a whole second tier of this involving foreign companies and governments as well. A ring of people working for the PRC were arrested or placed under warrant just last week.
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May 24, 2015 03:29
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Thanks for the advice, just trying to double-check and make sure everything checks out before I accept! Glad it's standard.
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May 24, 2015 05:05
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I've been posting on the corporate forum, but this is probably a better fit. I'm a computational biologist in a hospital / academic environment and one of my tasks is setting up and babysitting a set of databases. It shouldn't be a biggy - we use off the shelf stuff, everyone is supposed to be experienced and smart. Of course, it's blown up to consume my whole life. All due to just two users and a single, simple clinical db: * I wonder if they've ever used a computer before. I had to tell one how to open a spreadsheet. I get regular emails about how they've forgotten their password and can I please tell them. * Their laissez faire attitude to data privacy. Generate tables containing patient names and dates of birth? Sure, just email them around and put them in dropbox! I mean, the project ethics documents didn't say you couldn't! * Any change in the db or data and they're flinging scat at the walls. A test result disappears after an update? It couldn't be a correction, it must mean that I'm deleting data! Extra columns appear when the dataset is expanded? Obviously the db is utterly corrupt and unstable! There's a number of patients who have dropped out of the trial? Why are you removing patients, we need them all! * "When that dialog said the dataset you were trying to download was too big? It meant the dataset you were trying to download was too big." * The regular nagging emails: "Okay, we've been really patient thus far and you've had it easy. But now's the time to go all out and fix all this stuff and give us all the things we want and create all these other webservices and databases that we suddenly urgently need by next week. WE INSIST! WE INSIST!" * If I don't give them the answer they want (i.e. all the time), they cc in my line manager, his line manager and a bunch of random other people. I have literally hundreds of emails from them and I've only worked here a year. It hit a low point last month where they were demanding that I fix a bug that didn't exist, give them data that I didn't have and repair a computer system that I don't run and don't have access to to. I'm looking at job ads and if they even mention databases or infrastructure I skip it. Never again. Not even once.
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May 26, 2015 15:52
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outlier posted:Never again. Not even once. Laboratory Chat - Never again. Not even once. Are you folks getting some nice schadenfreude from the LaCour scandal? Front page of the new york times today! One thing the article doesn't entirely spell out, probably out of fear of liability, is that at this point, it looks like data was never collected. I've been discussing it with a colleague, and both of us were shocked at what a bad job the guy did at falsifying data. Disappointing- we'd expect better of someone published in Science. Discendo Vox fucked around with this message at 16:41 on May 26, 2015 |
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May 26, 2015 16:38
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Discendo Vox posted:Are you folks getting some nice schadenfreude from the LaCour scandal? Front page of the new york times today! One thing the article doesn't entirely spell out, probably out of fear of liability, is that at this point, it looks like data was never collected. I've been discussing it with a colleague, and both of us were shocked at what a bad job the guy did at falsifying data. Disappointing- we'd expect better of someone published in Science. Sometimes I feel like I'm the only one in science who doesn't fake their data. Guess that's why I never got any of those fellowships.
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May 26, 2015 22:50
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My favorite quote, from Dr. Green, the supervising, field-leader PhD who seems to have done no actual supervising:quote:I thought [his initial results] were so astonishing that the findings would only be credible if the study were replicated. (I also had some technical concerns about the “thermometer” measures used in the surveys.) Thermometer measures.  And here I am trying to find a single journal that will look at my mildly new theorywork. Thermometer measures. In Science.One of the better sources is, of course, Retraction Watch.
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May 26, 2015 23:56
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Hello, I know the theme of this thread is unrelenting pessimism, but I have a career question. My fiance has a BS in General Biology and has been working for 4 years at a small company that does testing on wastewater, solids, etc. Using live organisms and stuff (pardon, I'm no biologist, so I guess what I'm saying is, it's not high tech genetics or anything) She did bench work for a couple years, was the supervisor for a year, now does auditing/quality and process controls/owners right hand lady. She wants an out because the pay is pitiful (~35k in New England) and the owner is speeding towards retirement. She doesn't want to really do bench work and her father and I (quality engineers) told her to stay away from QA, so what are some key job titles to look up? She would like to do reporting and stuff like that... Im thinking things like entry lever project manager/coordinator, process engineering, but I'm just not very familiar with the field. Any advice? E; it is now painfully obvious I didn't even read this page, but I guess my question is a bit different? Crazyweasel fucked around with this message at 21:12 on May 27, 2015 |
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May 27, 2015 17:41
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Crazyweasel posted:Hello, I know the theme of this thread is unrelenting pessimism, but I have a career question. Why in the heck did you tell her to stay away from QA?
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May 27, 2015 22:37
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Yeah, I'm curious too. I've been thinking of getting into entry level QA cause it sounded like a nice balance between desk and bench work with possible $$ growth, but if there's something obvious I'm missing, or if the field has changed recently, it'd be good to know. I've been working 4+ years as a research associate at the same university I got my masters ('10) and bachelors ('07). I pull in the same amount as your fiancee, but we're rural so it goes further. Everything that I've looked at outside of USAJobs would put me at the same (or less) income in more expensive cities, so I've stayed here. I haven't gotten that restless because my PI is incredibly reasonable, lets me do 9-5 five days a week, I actually get time off for vacations, and my coworkers are overall pretty awesome. Is it really so bad to stay at the same institution when it's better than 90% of the lab-based workplaces I've read about out there? I get the feeling that maybe some people check out my resume and assume there's something wrong with me for staying at one place for so long. I'd be content to stay here another 10 years if it weren't for that nagging feeling of being judged for not having more ambition, and you know, having more money for retirement.
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May 28, 2015 04:35
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QA/QC just seems super boring to me, I can't imagine a life doing that. Then again nothing every works in research so there's that.
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May 28, 2015 04:45
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Zantie posted:Yeah, I'm curious too. I've been thinking of getting into entry level QA cause it sounded like a nice balance between desk and bench work with possible $$ growth, but if there's something obvious I'm missing, or if the field has changed recently, it'd be good to know. I just got out of a QA job in a food chemistry lab, and it was boring as poo poo. It's my fault for taking a spot in a Quality lab while having a Master's degree, but I had a lot of people at my company, particularly people above me, ask some variation of "with that background why the hell are you here?". I even had a recruiter today ask me point-blank why I never tried to move out of quality into a more knowledge-intensive department (I tried, multiple times to no avail). Perhaps this is due to the structure of my former employer, but the "benchwork" part of my job required very little chemistry knowledge, the last three full-time hires we made were all guys we stole from the production floor, with GEDs at best. I trained one of them in how to run things in the lab and by the time I left, he was one of the best people for benchwork. The further you went up the chain of command within my department the more your time got consumed by meetings, paperwork, and fixing other people's messes. In particular, we hired a new director last fall who had a PhD from a pretty well-regarded food chemistry program, and when he first came on I told him how interested I was in having some conversations with him about the field, and he expressed interest in talking to me about it, but he just never had the time. That being said it wasn't completely worthless, I did get a lot of exposure to how a business is run and some insight into corporate life that I wouldn't have gotten if I stayed in a lab all the time. Because my day-to-day work was so easy I had a lot of free time and energy to pick up some other skills and connections; in particular I led a fairly visible company-wide (non-lab) project that earned me a lot of accolades as well as a personal reference from the company president to the head of an industry recruiting agent (when he heard I was moving away). However, if you want to put your degrees to good use then stay out of quality, I don't know if other labs are like this but my former lab was on the fast track to becoming a glorified production wing by the time I left. Zantie posted:I've been working 4+ years as a research associate at the same university I got my masters ('10) and bachelors ('07). I pull in the same amount as your fiancee, but we're rural so it goes further. Everything that I've looked at outside of USAJobs would put me at the same (or less) income in more expensive cities, so I've stayed here. I haven't gotten that restless because my PI is incredibly reasonable, lets me do 9-5 five days a week, I actually get time off for vacations, and my coworkers are overall pretty awesome. If it's actually better than 90% of the labs you've read about, and you can't get into the 10% that are better, then you can't argue with that. You probably don't have much upward career mobility in an academic research lab, but from my experience if you're at a large enough university a department like that can be a great place to network. Also corporate entities prize loyalty to an institution more than they perhaps should, my supervisor at my old job got promoted to supervisor not because he was particularly good at what he did, but because he was the only one to stick around long enough to be considered for the role.
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May 28, 2015 05:54
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My degree is in zoology so it's not like I'm that great with chemistry anyway  I got hired on initially for my DNA/PCR experience, and since then I've learned some more molecular biology techniques, as well doing oil analysis using GC-FID and MS (along with some maintenance for the machines themselves). My desk work has been largely interpreting results, coordinating with the greenhouse, and writing up methods and SOPs. It's when people pointed out how detailed my notebook and reports were that I started thinking I could be good at QA. My PI is pretty happy with my loyalty, but our lab manager isn't going anywhere and without a PhD there's nothing else I could get bumped up to title-wise. The university just recently decided to reward research faculty by enforcing that stupid thing where no one can get above a "meets expectations" on annual reviews. I lurk in the TPS thread so my gut sank pretty far when I got the notice in April saying my score was retroactively dropped by some high-up guy I've never met. I'm not entirely sure where else I'd move up in the university considering that I've done the animal lab route and am tired of having to kill things for science, and the only offers I can get for teaching are all part-time/ temp adjunct or subbing That, and the pay for lecturing has gotten way worse and would be less than what I'd get in labs, so gently caress that. I have no personal research project wants, but I am curious as hell and love learning stuff so helping coworkers with their projects has been a pretty great balance so far. I don't do grant writing either, but some of what I've written has been in posters and publications, though obviously never as first author. I've also never been to a conference so networking outside my lab has been zilch. The last person in our lab with the same job title as me left to, I poo poo you not, drive a truck at a coal mine cause it more than doubled his pay. He dropped by the lab like a year later when he was in town visiting family, and the impression is that while the extra money is always nice, he was bored out of his mind. It's like, sure a lot of the bench work I do could be done by someone who has a high school or bachelors degree once they're shown how. But I thought one of the biggest perks of hiring someone with a higher degree, who won't just leave like a post-doc, is that you've got someone who don't need to be supervised and can more quickly and independently troubleshoot things when they inevitably go wrong...
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May 28, 2015 07:01
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Hey look, it's the exact reason I got the gently caress out of academia.
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May 28, 2015 09:40
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So she is the QA Officer now and doesn't like it much (can't hammer down exactly why other than boring/frustrating). My perspective of QA, being in aerospace, is that if you get in a big company you can make good  but in the long term it becomes a niche skill set that is highly dependent on personality and can pigeon hole you into a looked down upon support role.Also taking some time to read more, I can't believe the amount of education you need and the volume of people in the Chen/bio industry. I thought the log jam of boomers holding Sr. Engineering jobs was bad, but at least there is light at the tunnel when they all die...getting a MS and still doing bench work for $20/hr seems rough. Anyways, we got her resume in good shape last night, now we are figuring out what she really likes and dislikes and maybe for the sake of our future family income she will jump industries. In some ways I think it would be smart to get into aerospace QA just because the pay is crazy, but I dont want us to both be on the layoff train if/when it goes down again. I've been thinking maybe regulatory affairs for medical devices... Crazyweasel fucked around with this message at 14:22 on May 28, 2015 |
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May 28, 2015 14:17
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Crazyweasel posted:My perspective of QA, being in aerospace, is that if you get in a big company you can make good  As much as I loved working in a lab (that wasn't run by an owner who was batshit crazy), working QA in Aerospace is pretty awesome. Are you located north of Seattle by chance?
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May 28, 2015 14:31
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Zantie posted:It's like, sure a lot of the bench work I do could be done by someone who has a high school or bachelors degree once they're shown how. But I thought one of the biggest perks of hiring someone with a higher degree, who won't just leave like a post-doc, is that you've got someone who don't need to be supervised and can more quickly and independently troubleshoot things when they inevitably go wrong... That was definitely the case for me, I pretty quickly became a go-to person in the lab for both internal and external inquiries but that reliable nature came less from what I studied and more the fact that I had gone through some hardcore graduate research and could actually focus and give a poo poo about something for more that five minutes. I mean if you want to climb the industry ladder then you need industry experience, and QC/QA is as good a place as any to start because quality experience translates well across industry and it's a good mix of technical and corporate experience, but like that other guy said I could never do it as a decades-long career and you won't make nearly what you're worth (I started as a temp at $18/hr, got $18.75 when I went permanent, then for my top-tier performance review last year I got bumped up to $19.08  ).My advice is that if you really do want to make the jump between academics and industry and think you might like QA, find a QA job, see if you like it, make some friends for a year or two and then bounce. From what you posted having GC and MS experience, along with writing methods and SOPs, means you could probably get QA work pretty easily. And once you have even a little industry experience on your resume it becomes much easier to find that second job (at least I'm getting way more calls looking for job #2 than I did when looking for job #1) Speaking of industry jobs, I've gotten a couple calls from a guy who wants me to do some contract ICP-MS work helping to de-commission a nuclear power plant on the following schedule- 2015 June: 2 week training, California, 8 hr/day schedule Late Aug/early Sept: 1-2 weeks badging, Mexico, 8-10 hr/day schedule Late Sept/early Oct: 1-2 weeks equipment setup, Mexico, 10-12 hr/day schedule Oct 24 – Dec 5: Analyses performed to support chemical decontamination, 12 hr/day, 7 day/wk schedule 2016 Mid-Feb: 1-2 weeks setup, Mexico, 10-12 hr/day schedule Mid-March- April 24: Analyses performed to support chemical decontamination, 12 hr/day, 7 day/wk schedule They'd pay for all my travel but I'd get a per diem for living expenses in both Cali and Mexico (and "assistance" finding a place to live). Hourly pay with overtime, I told him I wouldn't do it for less than $35/hr and he immediately said he'd submit my profile with that pay so my gut says they have more money to spare. Is that schedule as miserable as it appears?
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May 28, 2015 16:18
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