Senior Quality Assurance Specialist
12 hours ago
At Clinical Resource Network (CRN), we are seeking a highly skilled Senior Quality Assurance Specialist to join our team. This role will be responsible for maintaining quality compliance for GMP production in North Caldwell, NJ. The ideal candidate will have a strong background in quality management and regulatory affairs.
Key Responsibilities:
- Maintain the quality management system to meet cGMP and regulatory requirements.
- Maintain all quality system documentation in accordance with cGMP guidelines.
- Responsible for leading FDA inspections and any vendor audits.
- Continuous review of QMS for evaluation and to drive process efficiency.
- Assist with executing development projects to define Quality strategy.
- Work closely with laboratory, development and operations teams to ensure Quality compliance.
- Assist with Annual Product Reviews.
- Manage complaint investigation procedures as required.
Requirements:
- Bachelor's Degree required
- Prior Pharma industry experience required
- 3-5 years relevant experience in a Quality organization
- Sound knowledge of cGMP guidelines
- MS Office proficiency
Clinical Resource Network (CRN) offers a comprehensive benefits program for hourly employees, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits.
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