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 mannerOwner of equipment within QCI and API Microbiology, perform OOT investigations as neededPerform or delegate BMS investigationsPerform or delegate OOT investigations for equipmentReview and Approve API Microbiology OOS investigationsOwner of DMR system and support for Change notification processPerform or delegate DMR investigationsRMA review and approvalOversight of all specification for receiving items/materials at siteSupervise 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 conThis individual will also supervise API Microbiology Laboratory and QCI personnel, conduct performance evaluation and ensure personnel training.Responsible for keeping track of Key Performance indicatorsRequirements:Minimum of five years of experience in a laboratory environmentMust 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 products2-3 years of Supervisor experience or direct oversight of a minimum of 6 individualsFamiliar with Good documentation practicesFamiliar with Quality System forms-Deviation Investigations, Event Investigations, Management of Changes, Building Management System Out of Specifications, Out of Tolerance Investigations, Microbiology Out of SpecificationsShould have experience with Documentation Revision in a quality systemKnowledge of JDE databaseMasterControlAny experience with Return Material Authorization (RMA)Discrepant Material InvestigationsEducation RequirementsThis position requires the following minimum education:Baccalaureate degree in Science/ Preferably in MicrobiologyJob Type: Full-timeBenefits:401(k) matchingDental insuranceHealth insurancePaid time offProfessional development assistanceVision insurance