GMP Quality Assurance Specialist
3 weeks ago
Job Summary: We are seeking a Quality Operations Specialist to ensure quality oversight of assigned projects/CMOs for the clinical/commercial product manufactured.
Key Responsibilities:
- Ensure quality oversight of assigned projects/CMOs for the clinical/commercial product manufactured.
- Work cross-functionally to provide updates and meet complex timelines for mission critical deliverables.
- Utilize risk-based principles and decision making to ensure compliance at all stages of development.
- Ensure compliance with relevant US, EU, and ICH requirements.
Requirements:
- B.S. degree in Life sciences, chemistry, or equivalent.
- 5+ years of GMP Quality experience with focus on cGMP compliance and product quality for US and EU. Drug Substance.
- Experience with using risk-based principles and decision making to ensure compliance at all stages of development.
- 5+ years of experience with relevant US, EU, and ICH requirements.
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