QC Associate - Bioassay

  • Fremont, CA, USA
  • Full-time

Company Description

Consider joining Lancaster Laboratories where people are the most important element in our chemistry.  Celebrating 50 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.

Eurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for a QC Associate - Bioassay to support our Professional Scientific Services group in Fremont, CA.

Job Description

QC Associate responsibilities include:

  • Perform analytical testing and wet chemistry practices for bioassay/immunoassay in a GMP environment (ELISA, SPR, Interferometry, cell culture, general aseptic techniques, FACS, fluorescence/luminescence/optical detection)
  • Conduct laboratory investigations, problem-solving and trouble-shooting for aberrant results
  • Review QC test results
  • Generate, review and maintain detailed records/documents and assist with QC data management and control charting
  • Prepare sample reconciliation reports, revise SOPs and training manuals, manage deviation and change control records
  • Participate in method validation and method transfer activities
  • Interface with other functional groups within and outside QC

The Ideal candidate will possess:

  • Demonstrated success in GMP regulated analytical environments
  • Familiarity with Softmax Pro, M3 plate reader, Biacore, Octet, Guava, Vydex
  • Critical thinking skills, ability to manage time, and attention to detail
  • Good knowledge of computer system validation, GMP and FDA, SUP and European regulations relating to material/product samples and testing
  • Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience.
  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment
  • Proficient computer skills and knowledge of Microsoft applications
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Qualifications

  • BS with 2-4 years  or MS with 1-2 years of experience in QC within the Pharmaceutical or Biotech industry, in a GMP or GLP regulated laboratory environment
  • Aseptic processing, clean room operations, compliance, sample handling/receipt/distribution, BioMES, data management/archiving experience
  • Experience with LIMS, SAP, Trackwise, IDEA, and/or NWA
  • Experience in performing investigations related to biopharmaceutical quality issues
  • Authorization to work in the United States without restriction or sponsorship

Additional Information

Position is full-time, Monday through Friday, 8:00 a.m. - 5:00 p.m., with overtime as needed.  Candidates currently living within a commutable distance of Fremont, CA are encouraged to apply.

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work.  We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

To learn more about Eurofins, please explore our website www.eurofinsus.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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