Lead QA Technician - 1st Shift
Core
Lead QA Technician ensuring product quality and regulatory compliance in pharmaceutical manufacturing operations.
Role type
Lead QA Technician (Pharmaceutical Manufacturing)
Builds
Pharmaceutical products and life-changing medicines
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, quality documentation systems (TrackWise, Documentum), label/CoA/CoC control, regulatory inspection support, root cause analysis, technical procedure interpretation
Preferred skills
Chemistry, Pharmacy, Biology, Biotechnology background
Technologies
TrackWise, Documentum, Microsoft Office
Responsibilities
Assure activities align with batch records, SOPs, GMP, and DEA regulations; Conduct critical reviews of GMP documentation; Review online batch records for completeness; Approve and control labels, CoA, and CoC documentation; Support regulatory inspections and customer audits; Review documents completed by operations personnel.
Seniority
Mid-level, hands-on IC
