QC Specialist

Location: Hybrid (2-3 days onsite per week)

Industry: Biotechnology / Gene Therapy

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.

• 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 Graph Pad.
• 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, Master Control, or ZenQMS.
• Partner cross-functionally with internal teams and external stakeholders to support program goals and continuous improvement initiatives.

Required

• 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.
• Experience supporting analytical method transfers, method qualifications, and method validations.
• Strong understanding of GMP regulations and product testing requirements.
• Experience supporting stability studies, including sample management, data review, and reporting.
• Hands-on experience with investigations, deviations, change controls, OOS, and OOT events.
• Proficiency with data trending and statistical analysis tools such as JMP and Graph Pad.
• Excellent organizational, documentation, and communication skills.

• Experience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic programs.
• Familiarity with ICH stability guidelines and analytical testing requirements.
• Experience with quality management systems including Veeva, Master Control, or ZenQMS.
• Experience supporting reference standard programs.
• Previous experience within a GMP manufacturing, testing, or biopharmaceutical environment.

This is an exciting opportunity to contribute to innovative gene therapy programs while working alongside internal subject matter experts and external partners. The role offers a collaborative environment, exposure to advanced modalities, and the opportunity to play a key role in ensuring product quality and compliance throughout development and commercialization.

This is a Contract position based out of Charlestown, MA.

The pay range for this position is $50.00 - $57.00/hr.

Individual compensation offered for this position within this range will depend on many…