Sr QA Technician: Batch Records Release (8hr days, Mon-Fri)
Core
Independently review complex or high-risk production records for GMP compliance and collaborate with operations to resolve documentation issues to ensure timely batch release.
Role type
Senior Quality Technician (Batch Records Release)
Builds
Sterile injectable and oral solid dose drug products
Domain
Pharmaceutical manufacturing / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance knowledge, batch documentation review, deviation assessment, cross-functional collaboration, regulatory audit preparation, SOP adherence
Preferred skills
Associate degree in Science or Technology, experience in cGMP environment
Technologies
Electronic batch record systems
Responsibilities
Review complex or high-risk production records for GMP compliance, Collaborate with cross-functional teams to ensure timely batch release, Provide guidance and on-the-job training for new technicians, Assist in preparation for regulatory and client audits, Lead initiatives to streamline batch review and electronic systems, Follow all job-related safety and training requirements