Quality Control Supervisor

Job Description Summary Responsible for managing day‑to‑day testing activities of the Quality Control group, including direct supervision of QC Technicians. Responsibilities Manages functional, day‑to‑day aspects of the Quality Control Department so that all Quality Control metrics, internal customer support, and individual/department goals are achieved. Supervises Quality Control personnel so that all of their individual and team objectives are met in support of the Departmental Objectives. Directs the work of Quality Control Technicians to meet routine and ad‑hoc testing needs for the Raleigh Mallinckrodt site. Handles administrative and personnel issues of the Quality Control Technicians; reviews and approves time‑card entries and time off requests. Manages all controllable cost items so that spending is at or below budget, including overtime scheduling/tracking. Manages the technical training and personal development of Quality Control Technicians, delivering performance reviews periodically to ensure all goals are met. Monitors laboratory activity for compliance with GMP and GLP, including instrument calibration and maintenance, procedure/method adherence, and facility/equipment conditions. Utilizes the Quality Management System to enter and investigate exceptions and out‑of‑specification results to support product disposition; creates and completes corrective/preventive action plans as necessary. Continuously implements improvements to make the Quality Control Lab run more efficiently and cost‑effective. Serves as a QC technical resource to support investigation of manufacturing plant problems and improvements. Provides support for the QC department during internal, corporate, and external regulatory agency audits and participates in audits and laboratory tours. Assumes responsibilities of the QC Manager duties in their absence. Assists other QC Department members to act as a backup for QC programs such as Finished Goods Release, Laboratory Hazardous Waste Program, Chemical and Testing Supplies Inventory, or Stability Program as assigned by the QC Manager. Conducts in‑process, raw‑material, finished‑goods, and/or waste‑water testing as needed. Performs other duties as assigned with or without accommodation. Qualifications Education: A Bachelor of Science degree in Chemistry or other Life Sciences, or equivalent work experience of greater than 8 years. Experience: With relevant degree, 5 years of applicable Quality experience preferred; without a degree, 8 years or more of applicable Quality experience required. Experience with Mallinckrodt QC Testing laboratory preferred. Strong understanding of general analytical chemistry techniques and principles, and general knowledge of chemical synthesis to understand plant processes and determine testing techniques. Knowledge of statistical principles to assure accuracy, reproducibility, and validation of methodology and personnel. Comprehensive understanding of Current Good Manufacturing Practices and Q7A to assure compliance. Knowledge of site safety and environmental policies. Understanding of proper personnel policies. Management and organizational skills to manage the functional operations of the lab and departmental personnel. Organizational Relationships and Scope Improper management of the lab could lead to product recall, missed shipments, and/or production downtime. The ability to make quick and good decisions is essential to keep the lab running and meeting internal and external customer needs. Sound technical judgments are required to assure product quality and integrity. All customer‑requested specifications and standard methods of analysis are confidential. Contact with plant personnel in all departments is required for effective supervision. Contact with customers is required during laboratory audits. Working Conditions Works in a modern, well‑equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments. A normal office condition area with adequate space and lighting is provided to handle computer work, paperwork, and personnel counseling. Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment and provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. #J-18808-Ljbffr Paladin Labs Inc.