FSP – QC Specialist – Raw Materials
Thermo Fisher Scientific
Summary
This is a fully onsite role based at our customer’s site in Foster City, CA. 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. This role has the potential to support the commissioning and setup of the QC Raw Materials laboratory and 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.
Job description
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, and 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 requirements for identity testing, qualification testing, and periodic verification as needed.
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, and document change controls.
- Support document review and approval workflows within electronic quality management systems.
- Ensure all specifications comply with applicable GMP requirements and internal quality standards.
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 requirements and quality expectations.
Deliverables
- Draft and complete approximately 150-300 raw material specifications during facility startup.
- Support creation of raw material master data requirements.
- Support equipment qualification activities as needed.
- Collaborate with project teams to ensure raw material specifications are completed according to facility startup milestones.
Working Environment
- 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.
Requirements
- Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or similar
- 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 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, which includes a drug screening
Benefits
- Medical, Dental & Vision
- Health incentive programs
- Employee assistance program
- Family support programs
- Commuter benefits
- Tuition reimbursement
- Paid time off
- Paid holidays
- Paid parental leave
- Accident insurance
- Life insurance
- Short-term disability
- Long-term disability
- 401(k) retirement savings plan
- Employee stock purchase plan
- Annual incentive bonus
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.