Our client is seeking a Senior QA Associate to maintain Quality compliance for GMP production in North Caldwell, NJ! The second shift will need to oversee 2nd shift production. The hours for this role are 3:30pm-12am Monday-Friday.
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.
Required Qualifications:
- 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 Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
