QC Laboratory Manager/Quality Engineer
Core
Lead QC laboratory operations and drive site-level quality engineering initiatives to ensure regulatory compliance and product quality in regulated manufacturing.
Role type
Manager, QC Laboratory & Quality Engineer
Builds
Quality control laboratory operations and quality engineering programs for pharmaceutical/medical device/biotech manufacturing
Domain
Life Sciences Manufacturing (Pharmaceutical/Medical Device/Biotechnology)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, ISO standards, quality risk management, CAPA/deviation management, root cause analysis, validation principles, regulatory inspection readiness, team leadership, cross-functional collaboration
Preferred skills
ASQ certifications (CQE/CQA), electronic quality management systems (TrackWise/SAP), project management, change control systems
Technologies
TrackWise, SAP
Responsibilities
Lead daily QC laboratory operations and supervise laboratory personnel; Ensure compliance with cGMP, ISO, and regulatory requirements; Drive quality engineering initiatives for risk reduction and process improvement; Lead investigations, deviations, nonconformances, CAPAs, and root cause analyses; Partner with cross-functional teams to improve manufacturing processes; Support validation activities and quality risk management programs; Participate in internal, customer, and regulatory audits; Develop and deliver quality-related training.
Seniority
Manager, hands-on leadership
