FSP – QC Specialist – Raw Materials

Thermo Fisher Scientific•Foster City, CA

3d•$93,000 - $98,000•Onsite

About The Position

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.

Requirements

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’)
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.

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 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 requirements for identity testing, qualification testing, and periodic verification as needed
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.
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 requirements and internal quality standards.
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.
Ensure raw material specifications align with current regulatory expectations for biologics manufacturing.
Support preparation for regulatory inspections, partner audits, and supplier audits.
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

Benefits

competitive remuneration
annual incentive plan bonus
healthcare
A choice of 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 paid time off (PTO)
10 paid holidays annually
paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
accident and life insurance
short- and long-term disability
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount