FDA-approved manufacturing plant in eastern TN (greater Knoxville area) has immediate opening for a Quality Lab Manager. This is a multi-million, state-of-the-art lab with an Analytical side and Microbiology side. This is a hands-on Lab Manager role that will lead Chemists and Microbiologists in the analysis of raw materials and finished products. Will ensure regulatory guidelines and cGMP requirements are met. The Lab Manager will also work with NCM investigations, deviations and CAPA's. Will interact with vendors to ensure the lab has proper supplies on hand.
Knowledge of wet chemistry, analytical chemistry, gas chromatography (GC), FTIR, and HPLC is preferred.
Qualified candidates will have BS degree in Chemistry, Biology or Microbiology, along with 7 years experience working with regulatory bodies such as the FDA. Technical background should include chemical theory, analytical methodology, laboratory instrumentation, and pharmaceutical analysis. Knowledge of 21CFR parts 210, 211 and 820 is ideal.
Relocation assistance is available.