Job Description
- Remote: East Coast candidates highly preferred
- High travel role to US and EU
Job Summary
This role supports Quality Assurance through cGMP auditing and supplier oversight within a regulated life sciences environment.
- Key Responsibilities
- Conduct GMP/GDP audits in alignment with internal and external audit programs
- Support additional GxP audits (e.g., GLP, GCP, GCLP) as needed
- Maintain audit schedules and track findings through resolution
- Manage supplier qualification activities and support Quality Agreements
- Monitor audit metrics, trends, and compliance data
- Assist with regulatory and partner inspections
- Provide QA review support for development documentation as required
- Ensure compliance with applicable FDA, ISO, and ICH regulations
- Contribute to broader QA initiatives as assigned
- Qualifications
- Bachelor’s degree or equivalent experience
- 5+ years in an FDA-regulated industry with strong cGMP knowledge
- Certified Quality Auditor (CQA) preferred
- Strong communication skills and attention to detail
- Ability to adapt in a fast-paced environment and collaborate cross-functionally
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