Quality Assurance Specialist

4 weeks ago


Fremont, California, United States Asahi Kasei Full time
Job Description

Bionova, a subsidiary of Asahi Kasei Medical, is seeking a Quality Assurance Compliance Specialist to join our team. As a rapidly growing biologics CDMO, we are committed to developing and manufacturing recombinant protein products using mammalian cell culture processes.

Key Responsibilities
  • Ensure products and processes meet established quality standards and regulatory requirements.
  • Conduct audits, implement quality control procedures, and collaborate with cross-functional teams to enhance product quality and compliance.
  • Provide training, support, and guidance to staff on quality standards and procedures.
  • Drive continuous improvement and ensure Bionova's processes are compliant and inspection ready.
  • Review and approve SOPs to ensure compliance with applicable regulations.
  • Support Supplier Quality Management qualification activities.
  • Monitor and analyze quality metrics and KPIs to identify trends and areas for improvement.
  • Act as a subject matter expert on quality-related matters.
Requirements
  • Bachelor's or higher degree in life sciences, engineering, or other related field.
  • 3-5 years of experience working in a GMP environment with direct work on manufacturing, quality, process development, and/or quality control experience in biotechnology or pharmaceutical industries.
  • Experience on biotechnology is a plus (Drug Substance manufacturing).
  • Working knowledge of cGMP regulations and guidance.
What We Offer
  • Competitive compensation package.
  • Health benefits at a subsidized rate.
  • Life Insurance and Disability Program.
  • Retirement Plan (401K) with up to 8% employer match.
  • Paid time off up to two weeks.
  • 10 days of Holidays and 5 days of Sick Leave.


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