Quality Assurance Auditor - Manufacturing
Core
Perform routine and non-routine Quality Assurance tasks to ensure data integrity, compliance with cGMPs, and quality standards in oral solid dose manufacturing.
Role type
Quality Assurance Auditor (Manufacturing)
Builds
Commercial and non-commercial oral solid dosage forms, including potent and orphan drugs
Domain
Pharmaceutical manufacturing (Oral Solid Dose)
Required skills
cGMP compliance, batch record review, SOP adherence, quality culture advocacy, data integrity, in-process QA checks, regulatory requirements knowledge
Preferred skills
None stated
Technologies
None stated
Responsibilities
Ensure integrity of data through accurate transactions and documentation; Provide advocacy for quality standards improvement; Support development of quality and safety climate; Ensure compliance to compendial and client-specific requirements; Perform in-process QA checks; Assure release of raw materials; Review batch records; Provide real-time support for manufacturing and packaging operations
Seniority
Mid-level, hands-on IC
