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Analyst, QC Microbiology

Newark, CA 94560

Posted: 09/11/2023 Employment Type: Contract Job Category: Scientific Job Number: 584398 Is job remote?: No Country: United States

Job Description

Duties:
  • Perform environmental monitoring of utilities and facilities
  • Perform LAL and Sterility testing of final drug product per compendial methods
  • Perform media growth promotion, gram staining, and microbial ID test methods of isolates per compendial methods
  • Perform TOC testing of water samples
  • Perform bioburden and LAL testing of incoming raw materials
  • Work with internal and external resources to maintain lab in an optimal state
  • Monitor and trend data
  • Assemble reports on findings from environmental monitoring of our cGMP facility, frequently update management on environmental trends and implement corrective action plans when necessary
  • Revise and review SOPs
  • Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Perform other duties as required

NEW REQUIREMENTS
  • Perform environmental monitoring of utilities and facilities and manage test data in LIMS
  • Perform Endotoxin and Sterility testing of final drug product per compendial methods
  • Perform media growth promotion, gram staining, and microbial ID test methods of isolates per compendial methods
  • Perform TOC testing of water samples
  • Perform bioburden and Endotoxin testing of incoming raw materials
  • Work with internal and external resources to maintain lab in an optimal state
  • Monitor and trend data
  • Assemble reports on findings from environmental monitoring of cGMP facility, frequently update management on environmental trends and implement corrective action plans when necessary
  • Revise and review SOPs
  • Assist in investigations regarding out of specifications (OOS) results and to address deviations related to microbiological procedures.
  • Follow GMP processes to ensure compliance with documented policies
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Perform other duties as required

Skills
  • Experience in the application of microbiological techniques such as air monitoring gases, water testing, surface monitoring, genus and species identification of isolates.
  • Experience in aseptic techniques and clean room operations
  • Experience in sterile gowning procedures
  • Strong knowledge of GMP, SOPs and quality control processes
  • Experience with EM System-MODA and Sievers M9s for TOC is a plus
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.


NEW REQUIREMENTS
  • Experience in the application of microbiological techniques such as air monitoring gases, water testing, surface monitoring.
  • Experience in sterile gowning procedures, aseptic techniques and clean room operations is a plus
  • Knowledge of GMP, SOPs and quality control processes
  • Experience with LIMS (i.e. MODA) and Sievers M9s for TOC testing is a plus
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Excellent interpersonal, verbal and written communication skills are   in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S.
Education:
  • Bachelor’s degree in Microbiology preferred with 1 year of experience in QC Microbiology laboratory setting



Pay Rate Range: $20-40/hr. Salary will be commensurate with experience

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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About Newark, CA

Explore exciting job opportunities in and around Newark, California! Situated in the heart of the San Francisco Bay Area, Newark offers an unbeatable blend of career advancement and quality of life. With easy access to Silicon Valley and major tech companies, as well as the cultural delights of nearby Berkeley and Oakland, this area is a magnet for innovative professionals. Enjoy the stunning views from Mission Peak Regional Preserve, indulge in diverse cuisines along the Niles Canyon Railway, catch a show at the Fremont Center for the Arts, or cheer on the San Jose Earthquakes soccer team at Avaya Stadium. Discover why Newark, CA is the perfect place to grow your career and explore new horizons!

Although this hasn't been an issue at Planet Pharma, 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.