Our client is seeking a QA Associate to assist in Quality compliance maintenance for GMP production in North Caldwell, NJ!

Responsibilities:

• Responsible for review and maintenance of production batch records.
• Maintain data integrity for all GMP related documentation.
• Assist with creating and maintaining company Standard Operating Procedures.
• Review Certificate of Analysis.
• CAPA implementation.
• Author, revise and track status of Standard Operating Procedures (SOP’s).
• Assist with the investigation process and manage change controls.
• Schedule any services required for certification and calibration.
• Responsible for document control processes.
• Assist with vendor qualification tracking.
• Will be involved with required regulatory and customer audits.
• Review accuracy of shipment inspection forms.
• Responsible for compiling information used for Annual Product Reviews.

Required Qualifications:

• Bachelors Degree required
• Prior Pharma industry experience is highly preferred
• 1 year of relative experience in a Pharmaceutical/Manufacturing environment
• cGMP guideline knowledge
• 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.