Quality Assurance Manager

2 weeks ago

St Louis, United States a Medical Devices company located in St. Louis, MO area Full time

Sr. QC Manager

RESPONSIBILITIES Ensuring the timely and accurate testing of materials and company products while maintaining and ensuring all quality and compliance requirements are satisfied. Providing oversight and guidance on day-to-day activities of chemists and biochemists in the QC laboratory. Defining, proposing, and driving solutions for technical problems within scope of work, and serving as an internal technical expert in physical, chemical, and biochemical testing activities utilized by the company. Supervising all QC laboratory operations, including testing of incoming materials, in-process samples, drug substances, and drug products. Managing departmental training, ensuring compliance with training plans, conducting hands-on training, and identifying retraining needs. Leading continuous improvement initiatives for compliance, quality, and technical operations. Overseeing QC investigations and deviations, implementing corrective actions (CAPA). Managing departmental inventories, coordinating with other departments as needed. Supporting senior management and contributing to strategic goals. Preparing and reviewing SOPs, Test Methods, Specifications, and protocols. Ensuring laboratory safety and compliance with regulations. Reporting laboratory metrics and addressing any performance issues. Assisting in preparing QC-specific Regulatory submissions. Directing and managing staff, including training, goal setting, and performance evaluations.

REQUIREMENTS Minimum 10+ years of experience in a GMP pharmaceutical QC laboratory. Minimum 7+ years of people management experience in a similar setting. Analytical fill finish /chemistry experience is REQUIRED. Coordinating testing and resolving problems with contract testing laboratories to meet commercial product timelines. Experience with budgeting and resource allocation for a commercial QC laboratory. Hands-on laboratory instrumentation experience and expertise in Capillary Electrophoresis and ELISA Strong knowledge of FDA cGMP requirements and USP testing standards. Proficiency in Microsoft Suite, chromatography applications, and LIMS systems. Hands-on experience with HPLC, GC, UV/VIS, and FTIR instrumentation. Expertise in investigative techniques, root cause analysis, and statistical sampling. Technical and management experience in GMP pharmaceutical Quality Control. Experience in developing and validating test methods and equipment protocols.

EDUCATION Bachelor’s Degree in chemistry or related field Master’s Degree in chemistry or related scientific field is a PLUS.

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