Associate Manager Quality Control
Core
Execute analytical method transfers, validations, and verifications for complex techniques while ensuring data accuracy and compliance with cGMP standards to support patient care.
Role type
Senior IC Quality Control Associate Manager
Builds
Safe and effective pharmaceutical products
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Required skills
Analytical method validation, HPLC, GC, IC, ICP-MS, Potentiometry, UV-Vis, FTIR, Karl Fischer, pH meters, cGMP compliance, ICH Q2/Q9 standards, OOS/OOT handling, CAPA management, change control, risk-based quality management
Preferred skills
Lean manufacturing, Six Sigma, statistical analysis, continuous improvement project leadership
Technologies
Empower, computerized databases
Responsibilities
Perform method transfers/validations/verifications, interpret and evaluate analytical data, review and revise SOPs, conduct analyses on finished products and raw materials, manage working standards, support process validation and troubleshooting, handle change control and CAPA actions
Seniority
Senior, hands-on IC with management responsibilities
