QA and QC Specialist
Core
Provide Quality Assurance oversight of Quality Control activities, including method validation, equipment qualification, and deviation investigations in biotech/pharmaceutical manufacturing.
Role type
Quality Assurance Specialist (GMP)
Builds
Validated QC methods, qualified equipment, and compliant process control documents
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP experience, Method Transfer Validation, Investigation, Change Controls, Equipment Qualification, HPLC testing, GC testing, raw materials testing
Preferred skills
Pharmacopoeia experience
Responsibilities
Review and approve QC method validation and equipment qualification protocols, Support evaluation and resolution of QC deviations, Contribute to process improvement initiatives
Seniority
Mid-level (4+ years experience)