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, material release assurance
Preferred skills
None stated
Technologies
None stated
Responsibilities
Ensure data integrity through accurate documentation of cGMP activities; Perform in-process QA checks; Review batch records; Assure release of raw materials and components; Provide real-time support for manufacturing and packaging operations; Monitor quality and safety standards; Advocate for quality improvement initiatives
Seniority
Mid-level, hands-on IC
