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.
