Quality Assurance Specialist, Batch Disposition

About the role

Location: Durham, NC (onsite). No relocation support. Shift: first‑shift and second‑shift (starting at 12:00 PM), Monday‑Friday.

Responsibilities

• Lead batch record review and batch disposition activities to support timely product release.
• Make quality-based disposition decisions for raw materials, consumables, intermediates, and finished product.
• Partner with Manufacturing and Quality teams to ensure GMP compliance throughout production operations.
• Support release of clinical and commercial products in accordance with regulatory requirements.
• Issue and manage batch records and associated manufacturing documentation.
• Review, author, and approve SOPs, work instructions, specifications, and other controlled documents.
• Drive investigations, deviations, CAPAs, and Change Controls impacting product quality and release.
• Support internal audits, regulatory inspections, and ongoing FDA inspection readiness activities.
• Monitor quality metrics and contribute to Quality Management Review reporting and site performance initiatives.
• Identify and implement continuous improvement opportunities that strengthen Quality Systems and operational effectiveness.

Requirements

• Bachelor’s degree in Biology, Engineering, Microbiology, Chemistry, Biochemistry, or a related scientific discipline.
• Minimum 5 years of experience in Batch Disposition and/or Quality Assurance within a GMP‑regulated environment.
• Proven experience performing batch record review and supporting product release activities.
• Strong knowledge of GMP regulations and quality systems within the biopharmaceutical industry.
• Experience supporting manufacturing operations, including cell culture, purification, or aseptic fill‑finish processes.
• Demonstrated experience managing deviations, CAPAs, and Change Controls.
• Experience supporting regulatory inspections and health authority audits, including FDA inspections.
• Strong attention to detail, sound quality judgment, and ability to manage competing priorities in a fast‑paced environment.

Benefits

• Comprehensive benefits package: health, life, and disability benefits.
• 401(k) with company contribution and match.
• Variety of other benefits.
• Generous time off package including vacation, personal days, holidays, and other leaves.

Pay

Expected salary range: $43.00–$80.00 per hour. Final salary based on relevant skills and experience, reviewed periodically. Includes performance‑based cash incentive and eligibility for annual equity awards (depending on role level).

Schedule

Monday‑Friday. Two shift options: first‑shift (standard daytime) and second‑shift starting at 12:00 PM.