FSP – QC Specialist –Biologics Raw Materials
Thermo Fisher Scientific · Foster City, CA
- Level
- Specialist
- Team
- Quality
- Base pay
- $93k–$98k
- Degree
- Required
- Experience asked
- 5+ years
- Industry
- Pharma & life sciences
- Posted
- 5 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, Supplier quality
- 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 October 19, 2026
Quality Engineer roles in California: typical posted base $100k–$149k. This one lists $93k–$98k.
Median of the low and high ends of 89 live postings that list pay, out of 189 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 188 other live quality postings in California.
- Base pay
- About 23% below similar roles
- Experience asked
- Typical (5+ years)
Typical $100k–$149k, from 86 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 77%
- FMEA 54%
- ✓ Supplier quality 49%
- Validation (IQ/OQ/PQ) 46%
- AS9100 43%
- ISO 9001 39%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for FDA / GMP, which few similar roles mention. If you have it, lead with it.
At a glance
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
Pick 2–3 people on the Quality team at Thermo Fisher Scientific
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 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.
- 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
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
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.
Full description from Thermo Fisher ScientificAs posted on their careers site.ShowHide
Key responsibilities
The QC Specialist - QC Raw Materials will support the startup and qualification of the new Foster City biologics manufacturing facility by developing, authoring, reviewing, and implementing GMP-compliant raw material specifications. In addition to specifications this role has the potential to support the commissioning and setup of the QC Raw Materials laboratory. This role will partner closely with Quality Assurance (QA), Manufacturing, Client Material Management, Supply Chain, Process Development and external suppliers to establish a comprehensive raw material specification program that supports clinical biologics manufacturing.
The successful candidate will preferably have strong experience in GMP documentation, and biologics raw materials.
requirements
for identity testing, qualification testing, and periodic verification as needed
requirements
and internal quality standards.
requirements
and quality expectations
Education and Experience
- ✓Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, 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.
Show full description ↓Show less ↑
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.
Raw Material Specification Development
- •Author and implement specifications for GMP raw materials used in biologics manufacturing, including:
- •Cell culture media and supplements
- •Buffers and process chemicals
- •Single-use system components
- •Resins and chromatography materials
- •Excipients
- •Primary packaging components and manufacturing consumables
- •Establish specification acceptance criteria using supplier data, compendial requirements, process requirements, and regulatory expectations.
- •Review and incorporate supplier Certificates of Analysis (CoAs), technical data sheets, and quality documentation into material specifications.
- •Define
Supplier and Material Qualification Support
- •Partner with Supplier Quality and Procurement teams to support material qualification and supplier onboarding activities.
- •Support raw material lifecycle management processes, including periodic review and specification maintenance.
GMP Documentation and Quality Systems
- •Author and revise GMP documentation including:
- •Raw material specifications
- •Material qualification reports
- •Document change controls
- •Support document review and approval workflows within electronic quality management systems.
- •Ensure all specifications comply with applicable GMP
Facility Startup and Readiness Activities
- •Support startup activities associated with commissioning, equipment qualification, and operational readiness of the raw materials testing lab.
- •Collaborate with project teams to prioritize specification development according to facility timelines.
- •Support development of raw material master data within ERP, LIMS, and document management systems.
Regulatory and Inspection Support
- •Ensure raw material specifications align with current regulatory expectations for biologics manufacturing.
- •Support preparation for regulatory inspections, partner audits, and supplier audits.
Cross-Functional Collaboration
- •Work closely with QA, Manufacturing, Process Development, GMAT, Supply Chain and Facilities teams.
- •Facilitate technical discussions with suppliers and internal stakeholders regarding material
Knowledge, Skills and Abilities
- •Minimum 5 years of experience in biologics, biotechnology, pharmaceutical manufacturing, quality control, quality systems, supplier quality, or raw materials management.
- •Demonstrated experience authoring specifications within a GMP-regulated environment.
- •Experience reviewing Certifi