Quality Control Supervisor (Pharmaceutical Manufacturing)
The International Society for Pharmaceutical Engineering, Inc.
Mission Statement: Our mission is the development and manufacturing of products that improve the lives of animals, while ensuring the safety, quality, and compliance of the products to the highest industry standards. Primary Function The Quality Control Supervisor/Chemist is a supervisory role for Quality Control Department. Objectives include assisting the QC Manager and QC department staff in general to meet the departmental expectations as identified below. The position will be supervision of 1-2 chemists and 1-2 QC Floor Technicians as well as a Microbiologist. Maintain the Stability Program. Oversight and hands‑on testing shall include but not be limited to microbial, chemical, physical, and research analysis. Objectives also include method development and method validation as instructed by management as well as performing non‑conformance investigations. Intermediate decision‑making skills are required for this position. Examples for decision‑making skills include prioritizing work, managing your time, and resolving daily challenges with duties listed below. Key Responsibilities As needed perform in‑process, finished goods, R&D and stability API assay by HPLC or wet chemistry techniques. Provide day‑to‑day work assignments and prioritize work load for the laboratory staff. Coordinate Stability Program—writing protocols, setting pull schedule, pulling sample, maintaining results and summary reports. Serve as back‑up for making in‑process batch adjustments by performing lab trials as instructed per the master batch record. Serve as back‑up microbiologist during vacations and PTO. Conduct OOS investigations. Write, review, and approve change controls, deviations, and quality investigations. Ensure all associates perform and document testing according to cGMP, SOP, and current industry practices. Ensure all associates maintain a clean work area including cleaning glassware, counters, and equipment. Keep the analytical laboratory supplies stocked and organized, and notify the manager when orders need to be placed. Train new lab associates on revised SOP, hands‑on analytical techniques, and continuous improvements. Assist with performance appraisals, coaching, and or disciplinary action reports. Other duties as assigned by management. Skills & Knowledge Required BS in Chemistry / Microbiology or related science field or equivalent hands‑on experience. Read and write fluently in English. Effective written and verbal communication skills in English. Reason and analyze technical challenges, moderate decision‑making skills. Perform calculations related to formulations, analytical lab work, and chemical concentrations. Ability to lead a small group by providing day‑to‑day instructions. Experience with HPLC and integration software, microbial sampling, and testing techniques. #J-18808-Ljbffr The International Society for Pharmaceutical Engineering, Inc.
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