Sr. Quality Control Analyst

Our client is looking to fill the role of Sr. Quality Control Analyst. This opportunity will be onsite in the Somerset, NJ area.

Responsibilities:

• In-process materials, raw materials, finished product, or stability sample analysis
• Supporting cell therapy products and associated assays
• Responsible for analytical test review and internal audit support
• Prepare COA/COT as required for testing performed
• Will identify Out of Specification and Out of Trend results related to phase 1 and 2
• Will participate with validation and technical transfer of analytical methods
• Responsible for writing stability and method validation protocols
• Provide required QC data necessary for regulatory submissions
• Support Quality System related activities and identify QC related deviations
• Role reports in the QC Manager in a fast paced, growing organization

Required Qualifications:

• Bachelor's degree (scientific discipline)
• 5+ years of experience of related experience in a cGMP environment supporting pharmaceutical manufacturing
• Prior method development and validation experience
• Prior cell therapy assay experience is highly preferred
• Knowledge of pharmaceutical cGMP regulation knowledge for US and EU

If you meet the required qualifications and are interested in this role, please apply today.

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.