FSP – QC Specialist – Raw Materials

Thermo Fisher Scientific • Foster City, CA

2d • Onsite

About The Position

The QC Specialist – Raw Materials will support startup and qualification of a new biologics manufacturing facility in Foster City, California. The role focuses on developing, authoring, reviewing, and implementing GMP-compliant raw material specifications and may also support commissioning and setup of the QC Raw Materials laboratory. The specialist will work with Quality Assurance, Manufacturing, Client Material Management, Supply Chain, Process Development, external suppliers, and other project teams to establish a raw material specification program for clinical biologics manufacturing.

The position includes preparing specifications for materials such as cell culture media and supplements, buffers and process chemicals, single-use system components, resins and chromatography materials, excipients, primary packaging components, and manufacturing consumables. The specialist will establish acceptance criteria using supplier information, compendial requirements, process needs, and regulatory expectations; review supplier Certificates of Analysis and other quality documentation; and define identity, qualification, and periodic verification testing requirements as appropriate.

The role also supports supplier and material qualification, raw material lifecycle management, GMP documentation and quality-system workflows, laboratory startup and readiness, raw material master data development in ERP, LIMS, and document management systems, and regulatory inspection and audit preparation. The expected startup deliverables include approximately 150–300 raw material specifications, support for master data requirements, and equipment qualification activities as needed.

This is a fully onsite position at a customer site in Foster City, California, with a standard Monday–Friday schedule in a laboratory setting. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening. Relocation assistance is not provided.

Requirements

• Bachelor’s degree in laboratory sciences, such as Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or a similar field.
• At least 5 years of relevant experience in biologics, biotechnology, pharmaceutical manufacturing, quality control, quality systems, supplier quality, or raw materials management.
• Demonstrated experience authoring specifications in a GMP-regulated environment.
• Experience reviewing Certificates of Analysis, supplier quality documentation, and technical data packages.
• Strong understanding of GMP regulations and ICH guidelines.
• Experience with electronic quality systems, document management systems, ERP systems, and/or LIMS.
• Strong technical writing, organizational, and project management skills.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening.

Nice To Haves

• Experience supporting startup, expansion, or commissioning of a QC laboratory.
• Experience with equipment qualification.
• Knowledge of USP, EP, JP, and other compendial requirements related to raw materials.
• Experience with supplier qualification, supplier audits, and change management programs.

Responsibilities

• Author and implement GMP raw material specifications for materials used in biologics manufacturing.
• Establish specification acceptance criteria based on supplier data, compendial requirements, process requirements, and regulatory expectations.
• Review supplier Certificates of Analysis, technical data sheets, and quality documentation and incorporate relevant information into specifications.
• Define requirements for identity testing, qualification testing, and periodic verification as needed.
• Partner with Supplier Quality and Procurement to support material qualification and supplier onboarding.
• Support raw material lifecycle management, periodic reviews, and specification maintenance.
• Author and revise GMP documentation, including raw material specifications, material qualification reports, and document change controls.
• Support document review and approval workflows in electronic quality management systems and ensure specifications comply with GMP requirements and internal quality standards.
• Support commissioning, equipment qualification, and operational readiness of the raw materials testing laboratory.
• Coordinate specification development priorities with facility startup timelines and project milestones.
• Support development of raw material master data in ERP, LIMS, and document management systems.
• Help ensure raw material specifications align with current regulatory expectations for biologics manufacturing.
• Support preparation for regulatory inspections, partner audits, and supplier audits.
• Collaborate with QA, Manufacturing, Process Development, GMAT, Supply Chain, Facilities, suppliers, and other stakeholders on material requirements and quality expectations.
• Draft and complete approximately 150–300 raw material specifications during facility startup.
• Support equipment qualification activities as needed.

Benefits

• Competitive remuneration and eligibility for a variable annual incentive plan bonus.
• National medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off and 10 paid holidays annually.
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance and short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• Career and development prospects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior