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QC Scientist - Microbiology

The QC Scientist is responsible for laboratory and operations environmental monitoring programs and process simulations.  This includes coordination of the EM programs, along with validation and qualification of methods, instrumentation, and processes. The QC Scientist may also perform environmental monitoring activities and microbiological testing.

  • Coordinates scheduling and prioritization of activities pertaining to plant environmental monitoring such as, compressed gas testing, water testing, viable and non-viable air particulate monitoring, and surface testing. 
  • Authors validation protocols and reports pertaining to environmental monitoring and process simulations.
  • Investigates environmental monitoring and personnel monitoring excursions and trends; leads corrective action/preventive action initiatives related to EM investigations.
  • Interprets and evaluates EM data for compliance with all regulatory requirements and corporate/internal procedures.
  • Trains Microbiology Analysts in environmental monitoring and microbial testing techniques.
  • Updates procedures, methods, and monitoring plans using change management system.
  • Interfaces with external partners, senior management, and regulatory agencies to discuss execution of environmental monitoring & process simulation programs at the site, as well as provide results and trends associated with the programs.
  • Provides subject matter expertise for standard operating procedures and quality standards content, as well as provide gap analysis to ensure that the programs are compliant with all regulatory requirements.

  • BS degree in Microbiology or related science discipline with a minimum of 5-10 years of experience, or MS degree with a minimum of 2-6 years of experience performing environmental monitoring.
  • A thorough understanding of aseptic plant operations and related environmental monitoring requirements along with the associated microbiological principles and procedures.
  • The successful candidate must possess the ability to work independently in a fast-paced environment.
  • Excellent oral and written communication, as well as strong technical and analytical problem-solving skills are critical. This position requires leadership/project management ability and a dedication to meeting timelines.
  • Job duties involve occasional lifting (less than 35 lbs), reaching, and sitting while working at computer terminal.
  • Expertise in SAP LIMs and MODA are highly desired.
  • Good oral, written and interpersonal communication skills are required. 
  • Candidate should possess basic computer skills such as data entry, and a high level of attention to detail is also required.
  • The successful candidate will also demonstrate the ability to organize time independently and prioritized their workload in order to meet objectives in a flexible, team-oriented environment. 
  • 5S and/or Six Sigma skills preferred.
  • Candidate must not be Cephalosporin/Penicillin sensitive