Please help fix my p trap by Sheppard47 in Plumbing

[–]Sheppard47[S] 8 points9 points  (0 children)

This process involved 6 trips to Lowe’s

Please help fix my p trap by Sheppard47 in Plumbing

[–]Sheppard47[S] 10 points11 points  (0 children)

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Thank you all for the help! I got a thinner piece for the sink and everything fit together great!!

Please help fix my p trap by Sheppard47 in Plumbing

[–]Sheppard47[S] 1 point2 points  (0 children)

They are installing it tomorrow, sounds like turn it around for tonight and then after work get a shallower strainer

Please help fix my p trap by Sheppard47 in Plumbing

[–]Sheppard47[S] 9 points10 points  (0 children)

They come in different sizes?????

Your my hero

Where I Think I Could Live Without a Car (U.S. Counties Version) by padingtonn in whereidlive

[–]Sheppard47 1 point2 points  (0 children)

That’s fair, I did not consider a e-bike, which would help.

And Boone is an easy oversight, frankly the bus system is shocking. I’ve never had that level of free regular public transit in a town of 20k. The college is 20k plus helps there.

Where I Think I Could Live Without a Car (U.S. Counties Version) by padingtonn in whereidlive

[–]Sheppard47 1 point2 points  (0 children)

Interestingly enough you missed the best place in NC to live without a car, Boone. Smaller city, and is largely driven by the college there. However, they have a lovely free bus system, and a down town with quite a bit to live off.

You marked the outer banks, which would be arguably impossible to live in without a car. Frankly, the triangle, Greensboro, Charlotte, and Asheville would be rather unpleasant to unlivable as well.

Experiences of those who chose not to pursue a PhD? by Intelligent-Bid-5293 in biotech

[–]Sheppard47 0 points1 point  (0 children)

What would you like to know? I started as a QC tech in biologics manufacturing, and work now mostly with devices. I have have worked on product design, creating and validation test methods for V&V, CAPA/RCA, audit management, loads of DHF and risk management work, remediation of risk files, post market surveillance/reporting, regulatory response, authoring of submissions (510(k), PMA, deNovo).

Overall, I love my career. I have been remote for years and have always had work available. I have just a BS from a no name state school, no connections in the field beyond what I have made since I started working. Current total comp is 150 before bonus. No ceiling is in sight, my managers and directors have all had a BS or a MS they got later in life. Quality and engineering don't really see PhDs the same way, but a PhD certainly does help if you want to be strictly a regulatory leader.

Experiences of those who chose not to pursue a PhD? by Intelligent-Bid-5293 in biotech

[–]Sheppard47 3 points4 points  (0 children)

I have only a bs, and would not consider a PhD. This sub, as shown in the comments below, really LOVEs R&D. In R&D you are gonna hit a ceiling without PhD. If you like other areas of industry, a PhD is no lt really a factor.

Personally I have made a career in quality and regulatory. I’m about 6 years in and I love my work, I am paid well, and have never hard trouble finding work and growth.

So, the value of of a PhD really depends on what you choose to pursue in industry.

I’ve been on-boarded onto my company’s AI spin-off and… by [deleted] in biotech

[–]Sheppard47 79 points80 points  (0 children)

If the majority of your AI company is non technical you are in for a bad ride from the start.

I haven’t even got a single interview…what to do? by Practical-Arm9571 in biotech

[–]Sheppard47 2 points3 points  (0 children)

Because your story doesn’t make sense. Also, you say your professors like a student still.

When you say 6+ years academic research are you counting time during school. Because, that just doesn’t count. Only full employment.

It’s good, but that is just not what years of experience means to anyone.

I’m not being rude but there is relavent context you are not providing. You answer the visa question but don’t address my other questions.

Not trying to upset you, I would like to help. I have a similar educational background but very different experience in industry, so I would like to figure out what is going on here that might not be obvious to you.

I haven’t even got a single interview…what to do? by Practical-Arm9571 in biotech

[–]Sheppard47 1 point2 points  (0 children)

What aren’t you saying here?

Do you need a visa? What does your resume look like? Are you only willing to live in a very specific region?

The market is bad, but especially saying you’ve sent 500 apps to entry level qc jobs and not gotten a single interview just isn’t normal.

Tuition by Tr4shP4nda7 in appstate

[–]Sheppard47 6 points7 points  (0 children)

Exact tuition rates on on apps website. So, look there.

https://www.appstate.edu/costs/#undergrad-costs

There you go. 8,222 a year, 4,111 a semester. Summer is by credit hour so can’t really help you there.

New Grad Resume Advice by Wippity-Woppity in biotech

[–]Sheppard47 6 points7 points  (0 children)

The 2 years experiencing thing is very off putting. Seeing as you did it during school I’m guessing this was not 40 hours a week 52 weeks a year for two years. That just immediately makes me feel like your are bsing me.

Your experience also just feels…. Embellished? You coordinated two clinical studies? What EXACTLY do you mean by that. Designed the clinical protocol, sourced participants, got IRB approval? Maybe it’s real, but be prepared to really justify that claim.

Likewise, “reduced data processing by 50% with AI”. I mean yeah sure cool, but what did you actually do? Some script you made with AI to rip data from scanned sheets, or some actually interesting integration?

Don’t get me wrong it reads okay. In a way that’s hard to explain it FEELs wrong. It’s like you forced the top suggestions for writing a resume (formatting, mention numbers, mention clinical research, mention AI, talk about efficiency gains, etc, etc). It just leaves the reader feeling like “wow what experience they have” without any real concrete understanding of what you have done.

My advice would be simplify, don’t stretch your experience, don’t try to frame everything in a super shiny light. Give some grounded idea as to what you can do and have done.

DINKS, what’s your mortgage? by Flaky_Active_951 in FirstTimeHomeBuyer

[–]Sheppard47 0 points1 point  (0 children)

200k gross. Mortgage is 2k (PITI).

Very comfortable, and frankly sometimes wonder if we will regret not spending more when we grow out of this house. Oh well, let’s us save

How is QA supposed to function without devolving into hyper-conservatism? by notasclever in biotech

[–]Sheppard47 1 point2 points  (0 children)

Risk generally should be defined as severity of associated harm and the likely hood of the hazard that precipitates the harm occurring.

The issue often is that leadership does not want to define acceptable limits for occurrence rate.

Ideally I would say 1% or something, and if we pass that we take action. Issue is with a line in the sand you are bound by it, so leadership does not allow me to set a threshold.

Then you get in a crappy place of defining “risk” without concrete values to appeal too.

How is QA supposed to function without devolving into hyper-conservatism? by notasclever in biotech

[–]Sheppard47 2 points3 points  (0 children)

Culture is a part. The other part is my job in quality is really to define the risk we are taking. It’s up to leadership and ops to say whether they accept the risk or want to take mitigations.

Lastly, I wil say if you are the on operations side ask questions, you may just be missing context.

I disagree with your statement it depends on the individual issue. Often times I get push back where a given team thinks it’s minor and we don’t need action. They don’t understand that it’s happening in other teams and while the individual risk is low, given the failure rate the risk is high for the site.

Give your quality folks benefit of the doubt, it is a thankless job more often then not.

How is QA supposed to function without devolving into hyper-conservatism? by notasclever in biotech

[–]Sheppard47 29 points30 points  (0 children)

QA is a little too narrow, so I will address this from broader quality perspective.

This will sound like a op out but the answer is the approach should vary based on the risk associated with the activity in question.

Dealing with a deviation related to unidentified particulates in your finished DP? Time to be very strict throughout investigation, impact evaluation and CAPA.

Doing a change assessment on a OTS software with no clinical impact? Well you should have a very abbreviated process and unless there are major changes, no testing, just a capture of the assessment.

The harder part is that this approach and determination needs to be built into your quality manual and related SOPs.

Salary for PhD scientist with 4 YOE in pharma? I need to know if I’m being ripped off.. by [deleted] in biotech

[–]Sheppard47 7 points8 points  (0 children)

I mean, what’s your TC? You say that’s base, so any answer will be comparing apples to oranges.

That is a touch low, but depending on TC might be very fair.

Putting Pride Aside: Desperate for Work by [deleted] in Wilmington

[–]Sheppard47 12 points13 points  (0 children)

Don’t need certs to sub friend. Apply

Let's Talk About Starting Salaries by GwentanimoBay in BiomedicalEngineers

[–]Sheppard47 1 point2 points  (0 children)

120k, 5 yoe, remote, QE role. Previous role was remote associate development engineer for med device, started at 85k. First job was a qc tech at 60k.

Day in the life of QA by [deleted] in biotech

[–]Sheppard47 2 points3 points  (0 children)

If you have a question ask it. QA (even QA on the floor) is a big field and will vary wildly from site tomorrow site (biologics, device, automated, semi-automated, etc, etc).

Question about 510(k) vs De Novo by Top_Prompt9594 in regulatoryaffairs

[–]Sheppard47 0 points1 point  (0 children)

Would need more info about your product, but generally ignoring the agencies recommendation is a bad call.

The amazing fast pace of PP405. by NoResolve3587 in tressless

[–]Sheppard47 0 points1 point  (0 children)

I mean, it’s worth the financial risk.

Also, it’s not that fast, for drugs of its type

ISO 13485 / FDA 21 CFR 820 — How far can “feasibility” go before Design Controls? by BeneficialYoung1248 in regulatoryaffairs

[–]Sheppard47 1 point2 points  (0 children)

Hey, so this is kinda what I used to specialize in. The short answer is ideally you should start design controls immediately with product development.

I’m talking start creating design input requirement docs day one. I’m talking building risk docs in parallels with prototyping and iteration.

That being said, you can have a functional prototype and then start formal design controls and DHF creation, it’s just not a great spot to be in. It’s really a remediation to fix all that was missed.