QA Associate

Piper Companies is currently seeking a QA Associate based in Summit, New Jersey for work at a leading pharmaceutical company. The QA Associate will support all activities for routine clinical and commercial product release.

Responsibilities of the QA Associate:

• Review executed batch records to ensure compliance with approved procedures and communicate discrepancies with manufacturing operators/supervisors
• Conduct quality walk-throughs of the production, testing and warehouse locations
• Ensure that all required documents are accurate, including all batch related deviations
• Oversee patient material receipt and drug product distribution
• Support routine preventive maintenance and calibration of equipment

Qualifications of the QA Associate:

• 0-2 years of relevant cGMP experience
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
• Hands-on experience with batch record review and product disposition is preferred.
• Bachelor’s degree in relevant science or engineering discipline is preferred or Associates degree and/or equivalent combination of education and experience is accepted

Compensation for the QA Associate:

• $27-$29/hr
• Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO

Keywords: GMP, GLP, GXP, GCP, batch record management, batch record review, full-process manufacturing, cell therapy, deviations, junior role, maintenance, calibration, FDA, EMA, biopharmaceuticals, quality assurance, QA