QC Bioassay Research Associate

Job Description

• 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

• 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.