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Shrieking Muppet posted:So had the eval meeting my with my supervisor, surprisingly she asked me if I would take on being the instrument bitch in our group. This would involve coordinating PMs, repairs and change controls. Part of the reason i left my last group was because i didn’t want to become the NMR mechanic. Now I’m here getting asked if i want to become a part time XRD/KF/DSC/Particle Size mechanic. Part of me wants to just tell no thanks but it would add job security. On the other hand the career path of onsite instrument mechanic is basically seems to only end with traveling instrument service engineer which I don’t really want. I was considering trying to migrate to method development since those jobs are usually more abundant but that leads to long hours and dealing with customers and makes me stay in pharma. Anyone have some suggestions on what questions i should ask about this role or own experiences being the instrument person? I'd only take it if your boss is reasonable. Things will break a non-zero percent of the time, and you need them to have your back when it comes to spending money or calling in professionals. Ask about maintenance budgets, service contracts, and how new instrument purchases are handled. Also ask about training courses. Most instrument manufacturers offer a 2-3 day course on servicing and method development. Get buy-in on taking those courses before taking the assignment. Obviously, these will be on hold for awhile due to Covid-19. Being able to take apart and put back together an instrument gives you a fundamental understanding of how something works. If you've never taken one apart, you'd be impressed with how simple a mass spec detector is. I can't believe they give such precise measurements given how simple the mechanism is. All the tuning parameters are voltages and alignment of a couple electromagnets and a ccd.
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Apr 7, 2020 22:57
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I have a lead at an organization located in the southwest where i want to move too. One thing about them that has me concerned is that they are a start up, from a chemist pov how is working for a pharma start up?
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Jun 30, 2020 22:21
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Shrieking Muppet posted:I have a lead at an organization located in the southwest where i want to move too. One thing about them that has me concerned is that they are a start up, from a chemist pov how is working for a pharma start up? It's not owned by someone like Elizabeth Holmes, is it?
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Jun 30, 2020 22:27
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Mustached Demon posted:It's not owned by someone like Elizabeth Holmes, is it? Not sure, would it be fair game to ask who owns said start up?
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Jun 30, 2020 22:49
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Shrieking Muppet posted:Not sure, would it be fair game to ask who owns said start up? Jokes aside, my advice would be to research everything you can about who started it and find their past works. Establish they have a history of actually getting stuff done. For me, the biggest concern would be you stuck in an environment chasing a pipe dream. Even worse would be a startup that gives gently caress all about safety.
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Jun 30, 2020 22:55
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Mustached Demon posted:Even worse would be a startup that gives gently caress all about safety. I think I might have actually applied to this job: https://www.journalnow.com/news/loc...1a4bcf6878.html
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Jun 30, 2020 23:10
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Mustached Demon posted:Jokes aside, my advice would be to research everything you can about who started it and find their past works. Establish they have a history of actually getting stuff done. For me, the biggest concern would be you stuck in an environment chasing a pipe dream. Even worse would be a startup that gives gently caress all about safety. Working analytical so more worried about getting poisoned to death, still have a call with them tomorrow and will get more info.
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Jul 1, 2020 03:25
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Shrieking Muppet posted:I have a lead at an organization located in the southwest where i want to move too. One thing about them that has me concerned is that they are a start up, from a chemist pov how is working for a pharma start up? I would say heavily dependent on the founder(s). Depending on the size, you will get to do a lot of different things and things can kinda unstructured. We do a lot of work for small and medium-sized US-based pharma companies and the variation in professionality is highly varying.
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Jul 1, 2020 06:49
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It'd almost be worth it to see the look on our QA dude's face if I tried to use these in a lab... Original Link: https://sfbay.craigslist.org/eby/tls/d/alameda-calibration-weights-set-7-piece/7144783928.html   The Listing posted:Selling a calibration weight set made of stainless steel with a hard case. The weights are 10 lb x 2 pieces, 5 lb x 1 piece, 2 lb x 2 pieces, 1 lb x 1 piece, 8oz x 1 piece. They are all in good condition. I am researching the value of them at this moment. Sell for best offer at this time. "I have somehow come into possession of a specialized set of calibration weights, but none of the paperwork, and have already ruined them. Here's a photograph of me ruining them. They may be Rice Lake. Here's a transcript of Rice Lake saying they don't sell them in that configuration and there aren't serial numbers where they should be. $399 please."
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Jul 8, 2020 00:24
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Sundae posted:It'd almost be worth it to see the look on our QA dude's face if I tried to use these in a lab... Also, he's missing the set of <10g weights that come with the kit.
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Jul 8, 2020 01:11
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I think the ruining is setting them on the driveway, but my quality level is in the poops > 1 time per day level, so I could be mistaken e- greater than or equal to, sorry for the confrusion, you see what i mean about my quality level
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Jul 8, 2020 01:57
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Im internally shrieking at that picture
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Jul 8, 2020 02:32
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Epitope posted:I think the ruining is setting them on the driveway, but my quality level is in the poops > 1 time per day level, so I could be mistaken Here's a larger picture.  Didn't use the handling tool, scratches, bird poo poo (?) on at least one of them, and then tossed them on some concrete for the photograph. quote:I can't see from the pics, but did he steal a set of calibration weights and file off the serial numbers? The serial #'s part confuses me. I've never heard of a weight-set without serials, so if it wasn't him polishing them off, someone did.
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Jul 8, 2020 02:50
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How do you know he didn't use the grasper to carefully place them on the pavement, hmmm?? The first time I saw weights in a mahogany box I thought it was bizarrely ostentatious. Now it's my go to example of how fancy can be functional. Though I'm not sure this guy would have gotten the hint.
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Jul 8, 2020 03:21
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My pharma company just lost all of May's air particle data from product fills on their lighthouse system. So glad I'm not admin for that system. the lots filled have already been released. I wonder how many more weeks it'll be until a formal deviation is actually opened and semi secret meetings stop being held...
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Oct 30, 2020 16:33
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If any of you work in an accredited lab (or otherwise), how are you validating/checking the performance of your thermal cyclers/PCR instruments? Ever since we got dinged during an audit a few years ago, we have to validate/verify every single analysis on every single specific instrument we intend to run it on, even if we already have it up and running on the same model of instrument (e.g. if we want to run a fragment length analysis of HTT on identical Veriti Thermal Cyclers A, B & C we have to validate it on all three of them). Obviously we want to get away from this to some sort of performance-based criteria, e.g. "Veriti A, B & C all perform to spec and the analysis is validated on Veriti A, so it is approved on run on A, B & C". The problem there of course is that we need to set relevant specs, and while I have a few ideas I'm curious how everyone else does it. Certain kits (especially IVD) come with their own specs, but a lot of what we do is homebrew, semi-homebrew or Research Use Only.
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Nov 17, 2020 18:22
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Any bioscientists here? I'm a software engineer with several years' experience working at an engineering firm, and afterwards in an imaging "lab". I'd like to join a research programme and wanted some guidance in identifying areas within life sciences where a trained software engineer might reasonably hope to improve the working practices of scientists. I'd like to find an area for improvement and develop an open-source tool - either for use within a specific field, or a generalised tool/platform to aid research methods and collaboration - which would form the basis of my project.
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Jan 5, 2021 12:32
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toadoftoadhall posted:Any bioscientists here?
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Jan 5, 2021 13:20
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toadoftoadhall posted:Any bioscientists here? If you have imaging experience already, there’s a good opportunity to write plugins for Fiji/ImageJ https://imagej.net/Fiji
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Jan 5, 2021 15:48
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I work for a medical device company and want to run something by this group. Namely, is there any advice for getting people to reliably follow our GDP SOP? Has anyone been in a company that was bad at it but then turned it around? Background info is we've had enough audit findings over enough years that it's been flagged as a systemic issue. It's been addressed to some degree before. We added a quiz to the training material (maybe we need to do re-tests?). We created in-person new-hire training about the importance of following procedures, including GDP (though the leadership level, even Director of Quality, will make GDP errors in quality records, so the culture is bad). We were denied going to digital management for some of our records, so they require completion by hand. This is a big-ish company with some silos. People leave blank spaces on forms and mess up date formatting all the time. It's crazy. And with working from home, people keep trying to use image copies of their signatures. I catch and force corrections on anything that goes through me, but not everything does. And the amount of corrections I have to make is starting to wear on my psyche. Right now I think the entire company would claim to understand that GDP is important but still not go through the mental hoops to actually execute it. There are edge cases of people not understanding how to do it, but I don't think that's the most common issue. Right now all I can think to do is ramp up the training requirements and try to update the forms so that GDP errors harder to make by design, but I'm not sure how to best do that. Long term we should start tracking metrics of GDP offenders, but there's not a good system in place to do that, and for now we are looking for a shorter term solution. Even if no one has any answers, thanks for listening to my rant. SmellOfPetroleum fucked around with this message at 05:47 on Feb 5, 2021 |
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Feb 5, 2021 05:40
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SmellOfPetroleum posted:I work for a medical device company and want to run something by this group. Namely, is there any advice for getting people to reliably follow our GDP SOP? Has anyone been in a company that was bad at it but then turned it around? I worked for a pharmaceutical company with GDP issues under consent decree. Our solution was PIPs and mass firings of people who couldn't handle it.
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Feb 5, 2021 05:53
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Sundae posted:I worked for a pharmaceutical company with GDP issues under consent decree. Our solution was PIPs and mass firings of people who couldn't handle it. Not gonna lie, but this is really what it’s going to come down to. Also, you need to hit everyone that touches the form, production and quality. More eyes and more responsibility means that there’s a greater chance of catching errors. But first, you can try to design out as much as you possibly can to prevent errors and you should do this. Also look at your processes to make sure that work is standardized as much as possible. Forms should have a common look and feel so that folks who are doing production fill out the same areas and QC/QA has their part and that doesn’t change from form to form either. This helps form that habit and also makes it really easy to check. The other thing is that you need to start checking, and get others to check as well. Can you force folks to spend time at the end of the shift double-checking paperwork? Are you easily able to pull the paperwork en mass and check yourself, or pull say everything from Wednesday? If you can do either, and management gives a poo poo, those numbers will start improving simply because folks know that someone is watching. Just make sure that in the process other corners aren’t being cut. Sometimes when you shine a light on something the roaches just scurry to a different dark corner.
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Feb 5, 2021 07:38
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If you don't have strong GDP culture, I don't know of a short term solution here. Our approach, also in a company under consent decree and extreme scrutiny, was to attach a 3-5 employee document review team to each laboratory. Operators could review and sign off one another's data if required to meet deadlines or deliverables, but without special circumstance, all handwritten material gets passed through two independent reviews, requiring signatures of each, before the data is considered part of the quality record. If it doesn't meet GDP it gets sent back to the originator for corrections. No results, materials, data, or reports leave the lab without the go-ahead from the document reviewers. For some of our more error-prone processes, or intermediate steps capable of process-ending errors, we would require a review signature on checkpoint paperwork before proceeding. Can't run the instrument without a signed permission slip. You can't error-correct until you error-detect, so effective review is critical. RadioPassive fucked around with this message at 07:55 on Feb 5, 2021 |
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Feb 5, 2021 07:42
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I wish we could've done mass firings and PIPs. Instead we just slowly gave the worst offenders fewer and fewer GDP responsibilities, and developed a culture of "please don't resent these fools for being so unproductive, if they tried helping it would be a disaster."
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Feb 5, 2021 07:46
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RadioPassive posted:If you don't have strong GDP culture, I don't know of a short term solution here. Oh absolutely on the error-detect/review as well. We ended up putting in an enormous oversight aspect too, with a full department of batch record reviewers, etc. We also had a broad re-write of the batch records to try to fix poorly-designed pages, remove unnecessary documentation, make it very clear where things needed documentation, blah blah. If operators still couldn't handle documenting things correctly even after that and after human performance analysis during investigations (tl;dr: assume the system failed the human until proven otherwise), then they got kicked to the curb. We didn't just go "here's the system, you're stuck with it, shape up or ship out." That never works.
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Feb 5, 2021 08:23
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Thanks for the discussion and advice. The investigation side of this is going to take a while, I think.
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Feb 5, 2021 15:26
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Sundae posted:We also had a broad re-write of the batch records to try to fix poorly-designed pages, remove unnecessary documentation, make it very clear where things needed documentation, blah blah. This is an often overlooked and very poorly understood dimension of GDP error prevention. Your procedural document lifecycle needs to include someone in the creation team who knows what the gently caress UI/UX is. A black and white clip art of a roadside stop sign does not magically improve operator precision when entering data on this form you rubes.
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Feb 5, 2021 18:29
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My boss countered my dead gay comedy forum info (I described it as networking when he asked for sources) with https://elsmar.com/elsmarqualityforum/ for industry savvy discussions. 90's era forums are the best. Sharing it here in case it's useful to anyone else. Or if it's already a known entity here, checking if there are red flags in its history I should know about.
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Feb 5, 2021 20:30
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Welp, going from R&D back into clinical. Pray for mojo.
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Feb 12, 2021 11:09
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Can anyone recommend helpful resources for undergrad students doing analytical chemistry coursework (books, practice exams, personal advice, etc.) or tell me whether or not many of these skills will be picked up easily enough through a job or internship? For context: My analytical chem course is being taught via a 100+ student WebEx (with entry and exit beeps enabled) straight from the textbook publisher's generic PowerPoint slides. 2 months prior to Covid lockdown I told myself that I'd never take any sort of math-centric online course again. I am seeking a B.Sc - Chemistry and do not plan to pursue graduate school at the moment so if I can scrape by with a C- to save 4 months of my time, and a couple grand I'm okay with it.
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Feb 13, 2021 20:19
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SmellOfPetroleum posted:I work for a medical device company and want to run something by this group. Namely, is there any advice for getting people to reliably follow our GDP SOP? Has anyone been in a company that was bad at it but then turned it around? Some limited fixes may work depending on the details of the form and violations (templating structures for dates, for example), but they can only resolve specific, small subsets of issues. The upper decision to not go digital where possible likely also means there's not will for a thorough standardization/design review.
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Feb 13, 2021 23:10
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Always fun to get an email to all staff from my University's VP of Research mentioning that the genomics core facility in my building (including its staff) is going away by this summer. When I wrote the director of said Core facility they also said they found out from the same email and the day prior when they had spoken with the VP had left it very much at "we will work on options with you". The core is probably the 2nd most widely used one on our campus and is used by 2-3 other nearby universities/colleges. According to its director it's only failed to turn a profit for 1 year out of the last 15 or so (and is currently in the black). Basically all of the instrumentation I need for the last 3 years of our R01 proposal is in that core which is 3 doors down from my lab. When pressing people in the VPs office about where the equipment will go and who will keep it running etc it was clear that they haven't yet figured any of that out. It's going to be really fun getting to go in and use a MiSeq that just becomes a free-for-all instrument with no staff to babysit it or make sure its not being abused. This is pissing me off a ton, probably 5 out of our top 7 most used instruments were in that facility and my startup asks were specifically negotiated down in some areas because I had access to these instruments. The one core that they mentioned moving stuff to for example is halfway across campus and only open from 9-5am which is uh... problematic when we do time-course microscopy assays on the confocal for 12-16h stretches for one of our assays. Anyways, needed to vent about this bullshit somewhere I guess.
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Feb 14, 2021 01:06
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That sucks.
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Feb 14, 2021 06:42
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Christ, that sucks.
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Feb 17, 2021 05:10
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RadioPassive posted:I wish we could've done mass firings and PIPs. Instead we just slowly gave the worst offenders fewer and fewer GDP responsibilities, and developed a culture of "please don't resent these fools for being so unproductive, if they tried helping it would be a disaster." I live in a similar hell. Also GMP/SOP training is a joke in my experience. Search for the answers and get it off my list of things to do. Seems to me we always needed real management in QC, more people staffing GMP production areas so people dont get overwhelmed and make errors and higher level management making sure departments are getting sent things they shouldnt have to deal with. But who cares about that when you can just force more work on the competent people.
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Feb 21, 2021 18:28
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I love when jobs post the skills and requirements of a chemist with almost 10 yrs of experience and want to pay the going rate of someone out of college. The pay rates are so messed up in Colorado/Denver Metro. Cannabis chemists get screwed for about $20/hr while pharma chemists like me make $45+/hr. The discrepancy is unreal, especially when people realize they've been under paid for their skills and they can come to my company and get literally double pay.
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Feb 23, 2021 17:18
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Cannibis chemists aren't on the hook for gmp paperwork/work habits in the same way. Unless you're in R&D gmp experience is a legit pay bump.
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Feb 23, 2021 18:31
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I dont know, cannabis chemists I interview tend to have better habits than most GMP chemists I've worked with. I'm in R&D though, so maybe I'm just out of touch.
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Feb 23, 2021 18:37
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I have 0 R&D experience so I can't speak to that side. But on the manufacturing qc side glp cannabis labs don't measure up to gmp qc labs in terms of process control and paperwork. Teaching someone documentation habits and how to always follow sops takes time and effort that not everyone is willing to do. Assuming of course you're not in a dumpster fire pharma company.
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Feb 23, 2021 18:57
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Spikes32 posted:Assuming of course you're not in a dumpster fire pharma company. 
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Feb 24, 2021 01:21
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