QC Specialist - Biologics Raw Materials

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.

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.

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 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
• 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

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.

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 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.

Preferred Qualifications

• 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.

Deliverables

The QC- Specialist will be expected to:

• 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:

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!

Compensation and Benefits

The salary range estimated for this position based in California is $93,000.00–$98,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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, and short- and long-term disability in accordance with company policy

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards