FSP - QC Specialist – Biologics Stability
Thermo Fisher Scientific
Summary
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.
Job description
Key responsibilities
The QC Biologics Stability Specialist will provide operational and technical support to the QC Stability Leads group in the execution of GMP-compliant stability programs. The role will analyze and trend stability data, generate stability summary reports, support regulatory submissions and shelf-life extensions, and assist with stability-related investigations and temperature excursion assessments. The QC Specialist will also create and revise stability protocols, maintain program trackers and shipping forecasts, monitor material transfers, and collaborate with stability leads and cross-functional partners to ensure stability deliverables are completed accurately, compliantly, and on schedule. The successful candidate will have experience with GMP documentation, biologics stability programs, data analysis tools such as JMP, and LIMS.
- Perform data analysis using JMP for quarterly trending and regulatory submissions.
- Generate Stability Summary Reports (SSRs) from LIMS for regulatory filings and inquiries, and Shelf-life extensions.
- Verify data for non-regulatory reports and support information gathering for stability-related investigations.
- Maintain and update molecule-specific stability trackers and shipping forecasts using Smartsheets and internal systems.
- Draft temperature excursion memos and initiate stability studies through protocol creation and revision.
- Populate and manage trackers for biologics programs and monitor material transfer reports.
- Collaborate with stability leads to ensure timely and compliant execution of stability program deliverables.
Education and Experience
- Bachelor's degree in lab sciences such Biology, 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
- Demonstrated experience in biologics Quality Control, including stability program support.
- Strong understanding of GMP principles and global regulatory standards.
- Proficiency in data analysis tools (e.g., JMP) and LIMS systems.
- Ability to develop and implement innovative solutions to complex problems.
- Excellent organizational, communication, and interpersonal skills.
- Proven ability to work independently and influence cross-functional processes.
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 Biology, or similar
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)
- Demonstrated experience in biologics Quality Control, including stability program support.
- Strong understanding of GMP principles and global regulatory standards.
- Proficiency in data analysis tools (e.g., JMP) and LIMS systems.
- Ability to develop and implement innovative solutions to complex problems.
- Excellent organizational, communication, and interpersonal skills.
- Proven ability to work independently and influence cross-functional processes.
- Must be legally authorized to work in the United States without sponsorship.
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 plan
- Employee stock purchase plan
- Annual incentive plan 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.