What does a QC/QA person do?
October 5, 2014 1:17 PM   Subscribe

What does a QC/QA position entail? I'm thinking more of science or manufacturing, and not financial/tax.

My bachelor's was in chemistry. I did lab tech work for a few years, I'm currently working a desk job in law. I've been thinking about what kind of job/career that'd have a bit of everything I've done and I got to thinking about my old lab's QA person.

On paper, it seems like QA/QC will meld what I have and like about all my prior experiences together (without too far specializing in each one): I'd have a science-related job, I'd get to do all the compliance/nitty-gritty detail stuff involving rules and regulations without actually being in the legal industry, and it'd exercise a good deal of technical writing (which I took a few courses of, was interested in, but I don't think it's suited to me as a FT position) for the SOPs once I move up from the technician stage into the auditing/internal compliance planning stage. So this is something I want to research more about.

However, QA varies wildly by industry. My local trade school has a QA certificate for manufacturing, but not much else. Ideally I'd like to tie in my science background more, but the market will control that more than me. So my question: what can you tell me about QA/QCing in general? Educational background required, working conditions, pay scale, whatever. Awesome bonus points if you can specify towards a laboratory/science based environment, although all thoughts in the manufacturing industry (I'm assuming that's more popular based on the availability of a cert in my area) or any other area would be welcome. I'm just trying to get a general idea of things even though I know specific duties will vary wildly by industry.

Thanks so much everybody.
posted by Zelos to Work & Money (6 answers total) 2 users marked this as a favorite
 
I work at a medical devices manufacturer, in R&D. My position requires oversight of the QC department so I have some exposure to how they are set up. QC techs tend to be bright, newly graduated science BSs, who don't seem to have any research experience. SOmetimes and associates degree is suffificent. THey do a lot of repetitive tasks according to SOP; they have very little role in writing or influencing the SOPs. They work hourly, rather than being salaried, but there's some opportunity for overtime. It's unusual for QC techs to move up through the management levels; very good techs (i.e., adept at learning and executing lots of SOPs in an efficient manner) are recruited to become R&D techs, because R&D requires the execution of a wider variety of tasks.

The people who are writing technical documents at my company and doing auditing/compliance tasks are those with more advanced degrees in science and engineering (PhD's and MAs), or more advance QA/QC degrees in manufacturing. Hope that helps.
posted by Tandem Affinity at 2:08 PM on October 5, 2014 [1 favorite]


I'll tell you in excruciating detail about my own career in case it is interesting or helpful to you. I've done both QA and QC, and now I'm in Scientific Affairs, and I too have only a bachelors, mine in Physiology -- no QA/QC certificate or anything like that. I spent a few years as a research tech in academic research labs first, and lab experience is what they want in QC.

I worked as a QC Chemist at a flavoring manufacturer and at a lab equipment and reagent manufacturer, and I made $17-20 an hour. QC chemistry is basically doing the same lab tests over and over as fast as you can (as fast as you can without making a mistake!) while the workers keep calling from the manufacturing floor looking for results so they can know whether the batch was good or not. It's kind of fun, the time goes by quickly, but I don't think most people want to stay in that job long because it is virtually brainless after a while. I loved working in a factory, what I did felt real, directly tied to a real product someone will buy and use.

I wrote some SOPs at the flavoring factory, so I was able to make the jump from the lab to a desk in QA in my next job, as a QA Technical Writer. I wrote manufacturing work instructions (like SOPs for specific products) and updated specs. I started at a soap factory at $21 an hour and went to $34 an hour in a little over two years. It's good if you like looking at virtually identical documents and finding the discrepancies, and writing instructions. QA is cool because you are the last line of defense between the consumer and bad product, and when there is a bad batch, there's a lot of problem solving. How can we make the process such that it's harder to make a bad batch that it is to make a good batch? I made these pictorial job aids in Photoshop showing step-by-step how to clear a jam on the tube filler or whatever, and that was really fun. Next was a drug factory, in QA, QA Technical Writer again, writing deviation reports -- a 400-500 word report of the investigation that I did into why a deviation from procedure occurred on the manufacturing lines, including a release disposition of the batch involved (OK or not OK) and recommendations to prevent it from happening again. The place was under investigation by the FDA at the time I was there, so my stuff was read by FDA people, so you know, no pressure. Maybe it was the FDA investigation thing, or maybe it was the pharma industry, but boy was that a terrible place to work. Very uptight, very adversarial QA vs. Manufacturing. I made $73K there.

Now I'm in Scientific Affairs at a dietary supplement company making $78K. I write reports proving the safety and efficacy of the ingredients in our products by searching the scientific literature, as well as various governments' regulations. Also when Marketing wants to say that lutein is good for cognitive health or whatever, I tell them whether I can substantiate such a claim. I miss working in a factory, and I miss the problem solving of QA, but the job is pretty cool if you like to read journal articles all day. I should note however that I am the only person in my 30-person department without an advanced degree. I will need one soon I think if I want to stay in SA. My job title is "Scientist", which is a little ridiculous for someone with only a BS (and no white coat).

So I hope that gives you an idea of what's out there, and what somebody's career progression might look like. Feel free to memail me if you have any questions.
posted by pH Indicating Socks at 3:14 PM on October 5, 2014 [1 favorite]


I work in regulation - basically external, mandated QA to a large degree. I don't know if the science field is different in some way, but I think it's likely the differences are smaller than the similarities with QA in other industries. At its core, QA largely involves testing <thing> against set standards and reporting on whether <thing> complies with the standard, possibly with recommendations for rectification activity (in my case, mandating rectification actions and evidence). Depending on the focus of the QA, it may also include making recommendations for changes to process etc to reduce likelihood of future non-compliances. There is also the broad area of 'business improvement' that often takes that next step in developing and revising processes and policies. In either case, good writing skills are paramount as is the ability to grasp the critical aspects of processes that you may not be technically familiar with. A certain amount of pedantry is useful, too.

In most areas, the relevant standards will be ISO or some variant of ISO standards and there are plenty of courses available related to these in your area that would be a good starting point. If you do a course, make sure it would be accepted by whatever is the QA accrediting industry body in your area. RAB-QSA might be a good place to start. Generally, you would need a Lead Auditor certification at a minimum, but not all situations will even require that.

QA is not for everyone, that's for sure (doubly so when it comes to regulation), but it can be truly rewarding and is the kind of role that gives you the feeling of actually making changes that matter. I can't advise you about pay or working conditions in your area, but my experience is that good auditors generally earn about the same or a bit more than the technical people doing the jobs they are assuring. If you're looking for variety in your work, external QA is likely to give you that much more than an internal role. Consider looking at the regulatory agencies that oversee the industry you're interested in.
posted by dg at 3:42 PM on October 5, 2014


I worked as a quality control chemist in pharmaceutical industry for a while. It was a mind-numbing boring job. I started out making $16/hour and eventual raised to $26/hour(salaried with benefits) after I moved across country. The company eventually ran into financial difficulties, the QC/QA department was on the chopping block. After unemployed for a year, I left the field entirely. There always going to be QC chemist positions available and they will be typically be a low paying job. I couldn't be happier with my decision to leave the field. Frankly, you don't need to know chemistry to work as QC chemist.

My typical day was to come in, read the Standard Operating Procedure(SOP) and run tests that I have done millions times before, usually on HPLCs. There are no freedom to change procedures because any changes in procedures would generate ton of paperworks that nobody wants to do. If there are any issues or deviations there will be an investigation that involved QA and I must write a report on how I could prevent same issues from occurring again and usually redo the test. Any mistakes will be a shitstorm. QC chemist who made too many mistakes will be fired. If I don't make it clear, everything you do, you MUST follow the procedure and write down your steps in a notebook. If the procedure tells you to jump off the cliff, you MUST jump off the cliff, then write in your notebook you jump off a cliff.

My interaction with QA primary involved notebook reviews and SOPs approval. QA will comb through the notebook and SOPs to find any obvious mistakes. Any concerns must be addressed to QA's satisfaction. People I interacted with in QA are smart, very meticulous and very through in their reviews. You must be a detailed-oriented person to be successful in any QA job. Obviously that's very small part of job description for QA position. If you are just starting out, you will most likely be reviewing notebooks and SOPs.

For Pharma industry. Good buzzwords bingo to know are GMP, CFR 21 and maybe ICH guidelines.
posted by Carius at 5:17 PM on October 5, 2014 [1 favorite]


I do not work in Quality. However, I do work in Biotech research and can tell you our AD of QA makes $140,000/yr (Boston, MA). Their function is primarily to drive the auditing process of our manufacturing vendors, work closely with CMC and drug labeling/packaging and to drive internal SOPs establishment and execution.
posted by floweredfish at 7:18 PM on October 5, 2014


I have worked in QA/QC in a scientific setting for about 15 years. As far as QA/QC jobs go, there are many different options. As mentioned above there is QC testing that is done on products (QC tech jobs). it's grunt work and usually involves doing repetitive testing. There are as many different tests are there are products. The pay/work is entry level.

Higher up the food chain are QA/QC jobs where you check data or daily processes within a lab (QA officer type jobs). This type of work can be done for any type of lab. You are not involved (or shouldn't be) in the day-to-day lab work but provide QA/QC tasks such as reviewing and validating data, reviewing/revising policy documents, creating QC charts, etc. You specifically do not do the work because that would be a conflict of interest. For this type of position, you need good working knowledge of the tests, regulations, and good lab practice.

The next level up is a QA/QC manager that oversees the entire program. This would involve maintaining/drafting the QA Manual, establishing program goals, maintaining oversight of the QA program, liaising with state/federal entities. At this level you need to be well versed in quality management systems like ISO 9000/19011, TNI, etc. The type of systems vary according to scientific field (medical? environmental? pharm?).

It's been my experience that folks don't go into QA/QC per se. You go into a field of science, get a job in a lab, learn everything you can about your job, train a ton, and finally go into QA/QC or management. A good candidate for this type of work has good technical skills, is organized, has strong technical writing skills, and can work with many types of people (especially those who are resistant to you).

I make a very good living at my job, but I have worked my way into a specific niche industry. I hope this helps! Good luck!
posted by jraz at 12:40 PM on October 6, 2014


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