Job description – Supervisor, QC – Microbiology

Cognate currently has an opening for a Supervisor position in the Quality Control-Microbiology department and is seeking a talented individual. At its core, the position requires working knowledge of Environmental Monitoring of GMP cleanrooms including how to appropriately and effectively complete investigations of excursions. Familiarity with compendial microbiological testing methods for sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.), is essential.
 

DUTIES AND RESPONSIBILITIES:

  • Previous experience supervising/scheduling staff for a 24/7 operation desired.
  • Experience with microbiology laboratory design requirements, setting-up/equipping, and inventorying.
  • Experience in culturing microbes and use of various classical microbiology and biochemical techniques such as gram stain, streak plate, spread plates etc.
  • Experience in data/statistical analysis, data trending, reporting results and presenting data in group and client meetings.
  • Excellent writing skills. Ability to draft Standard Operating Procedures (SOPs), protocols, reports, etc. Ability to write deviations, EARs, OOS reports, CAPAs.
  • Understanding of cGMP/GLP regulations as well as excellent GDP (documentation skills).
  • Familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of aseptic processes, biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically.
  • Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing and Quality Assurance.
  • Ability to multitask, problem solve and troubleshoot as necessary.

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • BS degree with 2-3 years of relevant Microbiology experience preferred or equivalent combination of education and experience
  • Ability to supervise and manage schedules of Analysts.
  • Ability and desire to take initiative on department-wide improvement projects and drive to completion.
  • Ability to work flexible hours, split shift and during weekends and holidays.
  • Experience performing and managing performance of Environmental Monitoring of GMP cleanrooms.
  • Ability to process large amounts of paperwork in a timely and efficient manner.
  • Ability to work in a team-oriented, multidisciplinary and multicultural environment.

 

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