Quality Assurance Associate

Our client is looking to fill the role of Quality Assurance Associate. This position will be hybrid and based out the Princeton office.

Responsibilities:

• Ensures GMP compliance for outsourced clinical manufacturing, packaging, labeling, and testing activities.
• Performs QA review of API and Drug Product manufacturing records for OPDC research & development products to ensure accuracy and compliance with Otsuka and GMP requirements.
• Performs QA review of Clinical Packaging records for OPDC research & development products to ensure accuracy and compliance with Otsuka and GMP requirements.
• Reviews analytical test results/raw data to ensure results meet specifications and are appropriately documented.
• Reviews quality events, deviations, investigations, and change controls.
• Escalates project/supplier issues/trends to GPQ Management when appropriate to ensure timely resolution.
• Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries to ensure compliance with local and global requirements and regulatory requirements.
• Utilizes the TrackWise Digital eQDMS System to enter batch related information and complete associated batch disposition workflow.
• Maintains GMP records (document storage, archiving, retrieval)
• Supports GPQ IMP R&D Metrics/Dashboards/Management Reviews by compiling batch record review/release data and/or other ad hoc reporting requests.
• Supports inspection readiness activities.
• Supports Trackwise Digital Quality R&D Division process improvement projects (UAM/UAT testing).

Required Qualifications:

• Bachelor's degree in Engineering, Chemistry, Biology, or related Science
• 2-5 years of related experience in pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product/Clinical Trial Material
• Ability to work independently.
• Ability to handle interactions and resolve issues with internal customers and GMP Vendors in a tactful, professional, and effective manner.
• Ability to manage and prioritize multiple tasks.
• Experience using MS Office (Word, Excel, PowerPoint)
• Experience using TrackWise Digital or similar eQDMS workflow interface.
• Excellent interpersonal and communication skills
• Thorough understanding of GMP requirements and the Drug Development process.
• Analytical problem solving and decision-making skills.
• Ability to identify gaps/risks and propose corrective and preventative actions.
• Experience in quality oversight of R&D/Clinical product manufacturing and packaging
• Experience in TrackWise Digital

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.