Overview
On Site
45 - 60
Contract - W2
Contract - 12 Month(s)
No Travel Required
Unable to Provide Sponsorship
Skills
PIP
Quality Assurance
Root Cause Analysis
Corrective And Preventive Action
GMP
Contract Manufacturing Organization
Regulatory Compliance
Manufacturing
Change Control
Job Details
Job Title: Mid QA Person-in-Plant (PIP)
Location: Morris Plains, New Jersey
Project Duration: 1 year with potential to extend
Pay Rate: $45/hr - $60/hr all-in rate (depending on experience)
Job Description:
Project relates to commercial manufacturing of CAR-T product at a CMO
Need additional QA oversight to support the batch releases.
This is a 12-month assignment with potential to extend.
The position will be responsible for 2nd shift working a 4x10 hour shift that will include some weekend and holiday coverage due to the manufacturing schedule and support required for this product. Shift is 2pm – 12am.
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.
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