Commercial Manufacturing Quality Assurance Specialist
Core
Support quality operations by reviewing batch records, ensuring compliance with FDA guidelines, and maintaining high standards of product quality for oral and specialty drug delivery.
Role type
Manufacturing Quality Assurance Specialist
Builds
Pharmaceutical products (oral & specialty drug delivery, biologics)
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Batch record review, Product release, Technical document drafting, FDA/GXP compliance, Quality program development, Process improvement, Equipment/room approval
Preferred skills
Six Sigma, ASQ certification
Technologies
GxP, FDA regulations, SOPs
Responsibilities
Perform batch record review, product release, and disposition; Draft, review, and approve technical documents; Ensure products meet FDA guidelines and internal SOPs; Participate in quality assurance program development; Train and mentor others; Assist with manufacturing floor activities including equipment and room approval.
Seniority
Mid-level, hands-on IC
