Sr. QA Operations Specialist – Visual Inspection
Core
Ensuring quality and compliance for visual inspection, final product sampling, packaging, storage, and shipment of pharmaceutical products.
Role type
Senior QA Operations Specialist (Visual Inspection)
Builds
Final product release and shipment compliance
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
Visual inspection expertise, AQL application, GMP documentation review, SOP creation, CAPA initiation, batch record review, training/qualification of staff, MS Office proficiency
Preferred skills
Bachelor's degree in scientific field, 5+ years in Visual Inspection/QA/QC
Technologies
MS Office (Word, Excel)
Responsibilities
Provide QA oversight of visual inspection activities; Coordinate cross-functional improvements for inspection and packaging; Monitor production schedules and communicate impacts; Inspect final packaged lots, bulk packaging, and perform sampling/retains; Create and approve product labels; Perform annual inspection of final product retains; Review batch records and GMP documentation; Write or revise Standard Operating Procedures; Initiate and own Quality Systems (Events, Deviations, CAPAs); Train and qualify new staff; Support site harmonization efforts.
Seniority
Senior, hands-on IC
