Senior Specialist, Sterile Drug Product, QA Manufacturing Operations Manufacturing
Core
Senior QA Specialist supporting the start-up and commercial operations of a sterile biologics manufacturing facility, ensuring compliance and quality for aseptic filling, lyophilization, and formulation processes.
Role type
Senior Specialist, QA Manufacturing Operations (Sterile Drug Product)
Builds
Commercial sterile drug product manufacturing lines (vials, syringes) and supporting tech transfer for new biologics.
Domain
Biopharmaceuticals / Sterile Drug Manufacturing
Required skills
cGMP compliance, sterile drug product knowledge, batch record review, change control assessment, CAPA evaluation, SOP development, GMP audit support, operational readiness, training program development
Preferred skills
Aseptic filling, lyophilization, visual inspection, MES implementation, 5S/Lean initiatives
Technologies
MES, MBR, CQV tools
Responsibilities
Provide QA oversight for aseptic sterile drug product processes (formulation, filling, lyophilization, capping, AVI); Review and approve batch records and functional area documentation; Support CQV, Tech Transfer, and Operational Readiness activities; Execute training programs for multiproduct manufacturing; Participate in GMP reviews for new facility construction and equipment; Support external and internal audits; Drive continuous improvement initiatives (5S, Kaizen, Problem Solving).
Seniority
Senior, hands-on IC