Pharmaceutical Quality Control Manager

The Quality Control Manager is responsible for overseeing all QC laboratory activities, including raw material, in-process, finished product, stability, and cleaning validation testing. This individual will manage laboratory personnel, review analytical data, conduct investigations, and ensure data integrity and regulatory compliance. Responsibilities Manage daily operations of the Quality Control laboratory. Develop, understand, and follow all QC laboratory related SOPs. Supervise and train QC analysts. Review and approve analytical data and laboratory documentation. Oversee testing of raw materials, packaging components, in-process samples, and finished products. Lead OOS, OOT, atypical result, and laboratory investigations. Ensure compliance with FDA cGMP, USP, and ICH guidelines. Maintain laboratory instruments and equipment qualification programs. Record and maintain QC Reference Standards and HPLC columns. Oversee stability programs and trend analytical data. Review and approve specifications, test methods, protocols, and reports. Support internal audits, customer audits, and FDA inspections. Collaborate with QA, Production, Regulatory Affairs, and R&D teams. Ensure compliance with data integrity requirements (ALCOA+ principles). Qualifications Required Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or related scientific field. Minimum 5 years pharmaceutical QC experience. Minimum 2 years supervisory or management experience. Strong knowledge of: USP testing HPLC Dissolution UV/Vis FTIR Method validation Stability studies Experience with OOS/OOT investigations. Knowledge of FDA cGMP regulations. Preferred Experience in generic pharmaceutical manufacturing. Experience supporting FDA inspections. Experience with Empower or similar chromatography software. Experience with solid oral dosage products. Skills Strong analytical and problem-solving abilities. Excellent leadership and team development skills. Strong written and verbal communication. High attention to detail. Ability to manage multiple priorities in a fast-paced environment. Competitive salary based on experience. Health, dental, and vision insurance. Paid time off and holidays. Retirement Plan. Health insurance Vision insurance #J-18808-Ljbffr Granulation Technology, Inc. (GTI)