QC Raw Material Release Supervisor Job at Stallergenes Greer U.S., Lenoir, NC

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  • Stallergenes Greer U.S.
  • Lenoir, NC

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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