Job Description

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

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