QC Specialist

About the role

We are seeking an experienced QC Specialist to support quality control activities across multiple gene therapy programs. This individual will provide oversight of external testing and manufacturing partners, manage QC and stability data, support analytical method lifecycle activities, and ensure compliance with GMP and regulatory requirements. The ideal candidate will have a strong quality control experience within the life sciences industry, experience working with CMOs/CROs, and a solid understanding of stability programs, analytical methods, and quality systems.

Responsibilities

• Manage and review quality control data generated by external contract manufacturing and testing organizations.
• Perform detailed review of release and stability testing data to ensure accuracy, completeness, and regulatory compliance.
• Analyze and trend QC and stability data using tools such as JMP and GraphPad.
• Support and maintain product stability programs, including sample tracking, data review, and reporting.
• Draft, review, and maintain QC documentation, including SOPs, specifications, protocols, reports, and Certificates of Analysis.
• Collaborate with Analytical Development teams on method qualification, validation, transfer, and fit-for-purpose assessments.
• Support reference standard management activities and associated documentation.
• Initiate and manage quality records including deviations, OOS/OOT investigations, impact assessments, and change controls.
• Provide technical oversight of external manufacturing and testing partners to ensure quality and compliance expectations are met.
• Utilize electronic quality management systems (eQMS) such as Veeva, MasterControl, or ZenQMS.
• Partner cross-functionally with internal teams and external stakeholders to support program goals and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, or another Life Science discipline.
• 5+ years of experience in Quality Control within a regulated life sciences environment.
• 3+ years of experience overseeing external partners, CMOs, CROs, and/or contract testing organizations.