Title: QA Person in Plant

Location: NJ

Length: 12+ months

Details: Client is ramping up commercial manufacturing of their CAR-T product at a CMO and need additional QA oversight to support the batch releases. This is a 12 month assignment with potential to extend. Commercial manufacturing just started beginning of February.

Day-to-Day tasks

• Provide Quality Support for Commercial Product Manufacturing:
• Oversee daily manufacturing activities, ensuring compliance with GMP and other regulatory requirements.
• Monitor production processes to ensure quality standards are met.
• On-Site Quality Support for Production Activities:
• Deviations and Investigations: Actively manage deviations that arise during manufacturing, perform root cause analysis, and oversee corrective actions.
• CAPA Review: Oversee the Corrective and Preventive Action (CAPA) process, ensuring timely and effective closure of identified issues.
• Escalation of Critical Issues: Take immediate action when critical quality issues arise, escalating as necessary to senior leadership or other stakeholders.
• Change Control: Review and ensure that all change control procedures are properly followed, assessing any changes to processes or procedures and their impact on product quality.
• Influence and Build Relationships with Internal and External Partners:
• Develop strong relationships with internal teams (e.g., R&D, Manufacturing, Regulatory) and external partners (e.g., the CMO and suppliers) to drive continuous improvement in quality performance.
• Support cross-functional teams to ensure alignment and the timely resolution of quality-related challenges.
• Provide Oversight of Aseptic Techniques, Risk Mitigation, and Gowning:
• Ensure aseptic techniques are followed throughout production to maintain sterility and prevent contamination.
• Oversee risk mitigation strategies to proactively identify and address potential quality issues.
• Ensure compliance with gowning procedures to maintain a controlled and contamination-free environment.
• Batch Release Activities:
• Act as a key player in the batch release process, ensuring that all product batches meet the required specifications and are released in compliance with applicable regulations and company standards.
• General QA Oversight (QA Generalist Role):
• Provide overall QA generalist support for the entire manufacturing process, offering guidance, troubleshooting, and support to the production teams.
• Monitor trends and ensure all QA systems are functioning effectively and efficiently.