Associate Manager Quality Control
Core
Associate Manager leading analytical method transfers, validations, and verifications to ensure product safety and efficacy in a GMP-compliant environment.
Role type
Senior IC Quality Control Manager (Analytical)
Builds
Safe and effective pharmaceutical products for patients
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Required skills
Analytical method validation, HPLC, GC, IC, ICP-MS, Potentiometry, UV-Vis, FTIR, Karl Fischer, pH meters, cGMP, ICH Q2, ICH Q9, OOS/OOT handling, CAPA management, change control, risk-based quality management
Preferred skills
Lean manufacturing, Six Sigma, statistical analysis, continuous improvement project leadership, troubleshooting complex processes
Technologies
Empower, HPLC, GC, IC, ICP-MS, Potentiometry, UV-Vis, FTIR, Karl Fischer, pH meters
Responsibilities
Perform method transfers/validations/verifications for complex analytical techniques; Interpret and evaluate data for accuracy and cGMP impact; Review and revise SOPs and analytical methods; Conduct analyses on finished products and raw materials; Manage working standards and change control activities; Monitor critical process parameters and support process validation.
Seniority
Senior, hands-on IC with team management responsibilities
