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Analyst I, QC Micro

Novato, CA 94949

Posted: 03/21/2023 Employment Type: Contract Job Category: Scientific Job Number: 548076 Is job remote?: No Country: United States

Job Description


PURPOSE

The QC Microbiology department is responsible for performing environmental monitoring and microbiological test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics.  

RESPONSIBILITIES

 Duties
  1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
  2. Perform daily bioburden and Total Organic Carbon (TOC) testing of samples collected from GMP facilities, equipment, and utilities.
  3. Routine cleaning and maintenance of QC biological safety cabinet (BSC) and laminar air flow (LAF) hoods.   
  4. Responsible for continuous upkeep and organizing of QC GMP records.
  5. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
  6. Perform shared general housekeeping activity assignments, including operation of autoclave sterilization of QC testing material.
  7. Assist with monitoring and the control of laboratory supply and critical reagent inventories.
  8. Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
  9. Perform other responsibilities as deemed necessary.

Education

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.
 

Skills
  • 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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