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Quality Control Analyst

Fremont, CA • Full Time

Job Description
Bionova is seeking a motivated and innovative QC Scientist looking to contribute to our expanding business. As part of the rapidly growing QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes.

Duties & Responsibilities

  • Perform testing to support production, raw material release, facility controls (environmental monitoring), stability studies, and standalone testing projects.
  • Interpret analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing.
  • Troubleshoot equipment and testing to identify root causes of issues.
  • Maintain equipment as appropriate per procedures.
  • Assist in QC team implementation of GMP procedures, processes, and systems.
  • Participate in development, transfer, and validation of analytical test methods (HPLC/UPLC, CE, ELISA, binding affinity, mass spectrometry and others).
  • Author/review/approve technical documents such as method validation and qualification protocols/reports, and regulatory filing documents per project needs.
  • Contribute to investigation of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.

Qualifications/Skills Required

  • BS in Physical or Biological Sciences or related disciplines. Preferred candidates have 5 years of relevant industry experience in a regulated cGMP laboratory environment.
  • Hands-on experience in laboratory methods, proper laboratory documentation, and safe laboratory practices.
  • Creative thinker that can identify better and more efficient methods to address issues and gaps.
  • Demonstrate ability to work independently and on cross-functional teams.
  • Strong attention to detail
  • Effective verbal and written communication skills

Eligibility Requirements

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.

Ready to Apply?
Please use the form below to submit your cover letter and resume.

Bionova Scientific is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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