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EM / Micro Supervisor

Job Responsibilities

  • Provide support within the Quality Control department for the testing and evaluation of environmental monitoring, microbiological status of product and in-process samples. 
  • Participation in the JHL Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending).
  • Participation in the generation and risk management (Specifications, Quality Systems, general application) and contributing to investigations pertaining to product, environmental, and raw materials and evaluating the impact of excursions on product and ongoing operations
  • Qualification and testing of microbiology materials in compliance with international regulatory standards.
  • Perform moderate data analysis and trending. Monitor data analysis and trends; notify management of issues and propose solutions to resolve them. Track and write investigation, CAPA, OOT and OOS reports.
  • Routinely train others in the application of GMP regulations. Train other QC Analysts in complex procedures and perform peer review of their work. Write and modify SOPs as needed. 
  • Work on a variety of problems of diverse scope. Begin to troubleshoot test methods, with guidance. 
  • Using thorough understanding of equipment, ensure proper equipment function, maintenance and documentation. 
  • Serve as “point person” for specific aspects of routine operations.
  • Normally receive only general supervision; may provide guidance to other EM staff. Need to plan and schedule the work of other QC staff.
  • Work across departments to proactively identify issues with broad impact and get them resolved.

Job Qualifications (Education, Certifications, Experience)

  • MSc degree with 5+ years experience in quality control systems or PhD with some microbiology related experience. 
  • Thorough knowledge of GMP regulations and documentation. 
  • Ability to train others in the application of GMP. 
  • Excellent verbal and written communication skills. Thorough understanding of quality control systems. 
  • Good overall understanding of the statistics required in relevant QC data analysis. 
  • Ability to work effectively across departments regarding qualitycontrol matters. Strong technical writing skills.