Quality Control Lab Manager

Job Overview Under the general direction of the Sr. Manager, Regulatory Affairs & Stability, the Quality Control Lab Manager is responsible for managing the AHP Quality Control Chemistry and Microbiology Laboratories. Responsibilities Produce and manage technical method transfer activities between suppliers and AHP laboratories. Direct, lead, train, and mentor laboratory associates; assign tasks and prioritize workload. Conduct investigations of unexpected results, coordinate communications with suppliers and laboratories, and document findings in MasterControl. Perform trending analysis for laboratory metrics to identify potential areas of concern in analytical reproducibility. Manage Environmental Monitoring program, TOC equipment, and water sampling for microbiology. Oversee laboratory testing of microbiology samples for LUD product release. Review and enter stability data; support the Quality Investigations team with requested analysis. Use process improvements to gain efficiency while maintaining quality. Ensure associates follow cGMP and safety procedures. Create, revise, and maintain SOPs, work instructions, and test method documents. Support manufacturing operations, including process validation, environmental monitoring, and utilities. Review stability and release tests for compliance to SOPs and regulatory requirements; report results accurately. Assist with root cause investigations for quality incidents; maintain Quality System records. Coordinate with departmental leaders to develop corrective actions and perform follow‑up checks. Qualifications Bachelor’s degree in chemistry or related field. Seven or more years of experience in a pharmaceutical manufacturing (cGMP) laboratory environment. Working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc.), and global Quality Control regulations. Experience in pharmaceutical stability testing (HPLC, Dissolution, Related Compounds, etc.), trending analysis, and investigation of unexpected results. Experience with method transfer protocols, stability testing, and data analysis for pharmaceuticals. Experience with MasterControl or other electronic quality management systems preferred. Skills & Knowledge Good oral, written, and interpersonal communication skills. Ability to develop and maintain cooperative working relationships with others. Effective interface with multiple levels of associates within the organization. Ability to work independently and handle a variety of tasks simultaneously. Attention to detail and familiarity with concepts of electronic documentation management systems (EDMS). Physical and Mental Requirements Physical activity requiring reaching, bending, kneeling, stooping, lifting, finger dexterity, grasping, feeling, repetitive motions, talking, and hearing. Ability to lift up to 50 lbs. Requires adaptation for close vision, distance vision, peripheral vision, and focus. Ability to stand, walk, or otherwise be mobile. Must handle stressful situations as they arise. Benefits Competitive compensation and benefits package. Medical, dental, and vision coverage. Comprehensive wellness programs focusing on physical, emotional, financial, and social aspects. Support for working families, including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. Training programs, professional development resources, mentorship opportunities, employee resource groups, and volunteer activities. Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. #J-18808-Ljbffr