QC Specialist – Biologics Stability

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 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:

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.

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