API/QCI Supervisor

Position Overview: Responsible for the release of raw materials, components, and finished products from QCI in a timely manner. Responsible for the release of in process and finished product results from API in a timely manner Owner of equipment within QCI and API Microbiology, perform OOT investigations as needed Perform or delegate BMS investigations Perform or delegate OOT investigations for equipment Review and Approve API Microbiology OOS investigations Owner of DMR system and support for Change notification process Perform or delegate DMR investigations RMA review and approval Oversight of all specification for receiving items/materials at site Supervise a group of 6 individuals that are in 3 different categories that are intertwined: API Microbiology, QCI, QC Material specialist. Organize and coordinate day to day operation such as work planning and workload prioritization. Coordinate time off to ensure coverage for workload. Work in cross departmental teams to assist with projects and high priorities for the business (on average week con This individual will also supervise API Microbiology Laboratory and QCI personnel, conduct performance evaluation and ensure personnel training. Responsible for keeping track of Key Performance indicators Requirements: Minimum of five years of experience in a laboratory environment Must demonstrate understanding in microbiology laboratory techniques such as bioburden testing, identification of fungal and bacterial organisms, identification of pollens, identification of mites/insects, purity checks for products, environmental monitoring, and aseptic technique. 2-3 years of document review for release of data, materials or products 2-3 years of Supervisor experience or direct oversight of a minimum of 6 individuals Familiar with Good documentation practices Familiar with Quality System forms-Deviation Investigations, Event Investigations, Management of Changes, Building Management System Out of Specifications, Out of Tolerance Investigations, Microbiology Out of Specifications Should have experience with Documentation Revision in a quality system Knowledge of JDE database MasterControl Any experience with Return Material Authorization (RMA) Discrepant Material Investigations Education Requirements This position requires the following minimum education: Baccalaureate degree in Science/ Preferably in Microbiology Job Type: Full-time Benefits 401(k) matching Dental insurance Health insurance Paid time off Professional development assistance Vision insurance