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QC Specialist – Biologics Stability

Thermo Fisher Scientific · Foster City, CA

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Level
Specialist
Team
Quality
Base pay
$93k–$98k
Degree
Required
Experience asked
5+ years
Industry
Pharma & life sciences
Posted
3 days ago

The role in 30 seconds

A specialist quality role at Thermo Fisher Scientific (pharma & life sciences) in Foster City, CA. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

They ask for
5+ years · degree required
Tools it names
FDA / GMP
Base pay
$93k–$98k
Day to day
relocation help

Read from the posting. The full description is below.

From the plant jobs report · week of November 9, 2026

Quality Engineer roles in California: typical posted base $100k–$150k. This one lists $93k–$98k.

Median of the low and high ends of 123 live postings that list pay, out of 249 quality engineer openings in California, read from manufacturers' own careers sites.

California plant jobs report →Pay by team and state →What moves pay →

How this role compares

Against 248 other live quality postings in California.

Base pay
About 23% below similar roles

Typical $100k–$149k, from 118 postings that list pay.

Experience asked
Typical (5+ years)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • Root cause 77%
  • FMEA 48%
  • Supplier quality 43%
  • Validation (IQ/OQ/PQ) 41%
  • AS9100 39%
  • ISO 9001 34%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 5+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone doing this work there first.

At a glance

Relocation helpLifts up to 25 lbs

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Quality team at Thermo Fisher Scientific

    We found 2 people at this company and state: 1 in this kind of role, 1 leaders. Engineers who joined in the last year or two reply the most. See them ↓

  2. 2

    Send a short, curious note

    One real question about their work. No favors yet. Each person gets a different note, written for this role.

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  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • How did you land the job? What stood out in your interviews?
  4. 4

    Apply with someone vouching for you

    If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.

  5. 5

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

This plant: Thermo Fisher Scientific in Foster City

1 other open role at this site · 2 people we found in quality roles at Thermo Fisher Scientific.

Full description from Thermo Fisher ScientificAs posted on their careers site.Show

Key responsibilities

The QC Biologics Stability Specialist will provide operational and technical support to the QC Stability Leads group in the execution of GMP-compliant stability programs. The role will analyze and trend stability data, generate stability summary reports, support regulatory submissions and shelf-life extensions, and assist with stability-related investigations and temperature excursion assessments. The QC Specialist will also create and revise stability protocols, maintain program trackers and shipping forecasts, monitor material transfers, and collaborate with stability leads and cross-functional partners to ensure stability deliverables are completed accurately, compliantly, and on schedule. The successful candidate will have experience with GMP documentation, biologics stability programs, data analysis tools such as JMP, and LIMS.

  • ◆Perform data analysis using JMP for quarterly trending and regulatory submissions.
  • ◆Generate Stability Summary Reports (SSRs) from LIMS for regulatory filings and inquiries, and Shelf-life extensions.
  • ◆Verify data for non-regulatory reports and support information gathering for stability-related investigations.
  • ◆Maintain and update molecule-specific stability trackers and shipping forecasts using Smartsheets and internal systems.
  • ◆Draft temperature excursion memos and initiate stability studies through protocol creation and revision.
  • ◆Populate and manage trackers for biologics programs and monitor material transfer reports.
  • ◆Collaborate with stability leads to ensure timely and compliant execution of stability program deliverables.

Education and Experience

  • ✓Bachelor's degree in lab sciences such Biology, or similar
  • ✓Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the

requirements

of the role.

Below is listed the working environment/requirements for this role

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance wit

Show full description ↓

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

This is a fully onsite role based at our customer’s site in Foster City, CA We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies

Knowledge, Skills and Abilities

  • •Demonstrated experience in biologics Quality Control, including stability program support.
  • •Strong understanding of GMP principles and global regulatory standards.
  • •Proficiency in data analysis tools (e.g., JMP) and LIMS systems.
  • •Ability to develop and implement innovative solutions to complex problems.
  • •Excellent organizational, communication, and interpersonal skills.
  • •Proven ability to work independently and influence cross-functional processes.

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