Manager / Sr. Manager, Quality Control

A brief overview The Manager / Sr. Manager, Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations. This individual is responsible for managing and coordinating stability testing, raw material qualification, testing and release, and validation projects. The Manager / Sr. Manager coordinates both in-house and contract laboratory testing activities. Additionally, this individual supports the Director, Quality Control in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the Quality Control department. What you will do Manage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel Establish and revise specifications and sampling plans for IPC, raw materials and final product Develop and optimize new and existing analytical methods for qualification and release testing Coordinate stability program and the testing to meet stability endpoints, as needed Manage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedules Write, review, and approve QC Standard Operating procedures (SOP’s) as needed Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrences Manage external test laboratories for contract testing of raw materials and other related testing Review test data for completeness and accuracy Provide timely responses to internal and external inquiries Stay abreast of new developments in analytical technologies Contribute to improvements in laboratory operations to increase efficiency and GMP compliance Qualifications Bachelor's degree in a relevant scientific field with a minimum of 8 years’ industry experience Master's degree in a relevant scientific field with a minimum of 5 years’ industry experience (preferred) PhD in a relevant scientific field with a minimum of 2 years’ industry experience (preferred) 1-3 years’ management experience (preferred) 1-3 years’ experience in managing projects (preferred) Extensive experience in GMP laboratory testing such as IPC, HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc. Thorough knowledge and understanding of analytical chemistry, including USP materials testing Creativity to solve technical and compliance problems Comply with good housekeeping and safety practices Experience in writing standard operating procedures (SOP’s) and test methods Excellent written and oral…