Quality Assurance Specialist
4 weeks ago
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.
- 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.
- 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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Quality Assurance Specialist
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