Quality Assurance

  • location: Novato, CA
  • type: Contract
  • salary: $20.10 - $23.65 per hour

job description

Quality Assurance

Analyst, QC I (Microbiology)

Job Summary

The Quality Control Microbiology, Environmental Monitoring, Analyst I under direct supervision, is responsible for performing microbiological, biochemical, and chemical evaluations of the manufacturing facilities, utilities, and equipment. With experience they would perform as a back-up for QC In-process and QC Microbial ID testing.

Job Responsibilities

  • Under direct supervision, the incumbent will be primarily responsible for performing environmental monitoring sampling and testing of the facilities, equipment, and utilities under cGMP guidelines.
  • In addition they will be responsible for performing biochemical and microbiological assays of samples under cGMP and GLP guidelines.
  • Work assignments will encompass activities from routine to semi-routine in nature with the ability to recognize deviations from accepted limits and practices.
  • The incumbent will be responsible for completing assignments in a timely manner, for assisting with troubleshooting, assisting with data trending, and for follow-up on any testing issues or excursions.
  • Good record keeping, organizational, written and verbal communication skills are essential.
  • Functional activities could include: supporting process validation studies, contributing to investigations, method validations, assay method/procedure development, reagent preparation, in-process microbiological and analytical testing, growth promotion of media, and microbiological identification testing.
  • The position requires knowledge of, but is not limited to, aseptic technique, microbial challenge studies, bioburden determination, microbiological method validation, endotoxin, protein, activity, TOC, and other similar analysis methods.
  • The incumbent must be willing to work second shift, overtime, weekends, and holidays as required.
Education & Qualifications

  • Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience.
  • QC cGMP experience beneficial.
  • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.
  • Demonstrated working knowledge related to specific functional activities.
  • Ability to perform most tasks with supervision.
  • Computer literacy is required.
  • Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.
  • Must have excellent record keeping, written and verbal skills.
  • Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays.
  • Efficient in scheduling and facilitating the execution of routine and non-routine testing.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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