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QC Associate - Microbiologist

San Mateo Metro Area, CA

Posted: 07/11/2019 Job Type: Scientific Job Number: JN -072019-25211
  • Performs environmental monitoring of plant utilities and production clean zones using particle counters, contact plates and microbial air samplers.
  • Performs routine and non-routine microbiological testing such as water bioburden and media growth promotion; Gram staining and microbial identifications.
  • Performs enumeration and characterization of microorganisms recovered from samples.
  • Assist with data analysis, troubleshooting and problem solving.
  • Perform testing according to Standard Operating Procedures (SOPs) and/or GMPs.
  • Works under direct supervision from management on routine tasks, and with general instructions on new assignments
  • Works on problems of diverse scope where analysis of data requires a review of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • May support validation activities, troubleshooting and SOP revisions.
  • Maintains accurate and well-organized laboratory records, notebooks and/or worksheets.
  • Performs other duties as may be required or necessary.
  • Follow all hazardous materials and hazardous waste management regulations and guidelines.
  • Ensure compliance with GMP/HSE regulations, company policies, procedures and standards as appropriate for the role.
  • Champion a Quality Culture and ensure a safe working environment.
  • As appropriate, responsible for implementation of, compliance to, and governance of practices and principles specifically prescribed to this role by the company Operational Standards for Supply Chain Excellence.
  • Demonstrates and role models the company s values and behaviors
  • 1 year or more experience in the pharmaceutical industry working in a GMP environment is preferred
  • Must have a demonstrated working knowledge of scientific principles.
  • Strong oral and written communication skills are required.
  • Previous hands-on practical laboratory experience is required.
  • Strong organizational skills are required.
  • Must have demonstrated problem solving abilities.
  • Knowledge of FDA regulations and cGMP s for drugs and device are a plus.
  • Knowledge of USP and EP tests, such as microbial enumeration tests and bacterial endotoxin test is desirable.
  • Bachelor's degree in Microbiology, related scientific discipline, or equivalent experience may be accepted.
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