FSP – QC Reviewer – Biologics Data Review

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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 Reviewer - Data Review is responsible for supporting Quality Control (QC) data review and governance activities for biologics products. This role ensures the accuracy, completeness, and compliance of analytical data and documentation generated by contract laboratories in support of product release, stability, method qualification, method transfer, validation, and regulatory activities. The incumbent collaborates closely with external QC laboratories and cross-functional partners to identify and resolve data and documentation issues and maintain compliance with GMP requirements, data integrity principles, and quality systems.

• Perform data review and reporting activities supporting release, stability, qualification, transfer, and validation activities in accordance with approved procedures. Identify trends, patterns, or issues in the data and communicate findings to support timely review and approval activities.
• Identify and escalate discrepancies, documentation issues, and potential data integrity concerns.
• Support review metrics collection and data trending activities.
• Participate in document revisions, process harmonization efforts and continuous improvement efforts.
• Support deviations, investigations, and CAPAs associated with data review and governance.
• Support regulatory submissions, inspections, and health authority responses through authoring, QC data review, technical assessments, and preparation of supporting documentation.
• Perform QC data verification activities to ensure accuracy and completeness and compliance of records
• Demonstrate working knowledge of GMP requirements, data integrity principles, and quality systems.
• Collaborate effectively with QC leads, laboratories, and cross-functional partners

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 2-5 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:

• Perform data review and reporting activities supporting release, stability, qualification, transfer, and validation activities in accordance with approved procedures. Identify trends, patterns, or issues in the data and communicate findings to support timely review and approval activities.
• Identify and escalate discrepancies, documentation issues, and potential data integrity concerns.
• Support review metrics collection and data trending activities.
• Participate in document revisions, process harmonization efforts and continuous improvement efforts.

…