Job Description

QC ASSOCIATE RESPONSIBILITIES INCLUDE:

• Perform analytical (UV/Vis, qPCR, SDS-PAGE, Western blot, CGE), compendial testing (pH, osmolality, turbidity, appearance), particulate analysis (HIAC, MFI, visible inspection), and drug product device functional testing (break loose/extrusion, auto injector functionality, container closure integrity) in a GMP environment
• Conduct laboratory investigation, 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:

• 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
• Demonstrated success in GMP regulated analytical environments
• Familiarity with Zwich, qPCR, icIEF
• 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

• Bachelor's  degree in biology, chemistry, or other related degree concentration
• 1 – 2 years of experience in Quality Control within the Pharmaceutical or Biotech industry, in a GMP or GLP regulated laboratory environment
• Authorization to work in the United States indefinitely 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.