Quality Person In Plant (QPIP)

Piper Companies is currently seeking a Quality Person in Plant (QPIP) to support cell therapy manufacturing for a CAR T manufacturing facility in Raritan, New Jersey.

Responsibilities of the Quality Person in Plant (QPIP):

• Resolve manufacturing issues along with daily review of manufacturing investigations, change controls, complaints, and CAPAs

• Work to drive compliance to limit non-conformances

• Perform reviews of batch records, procedures, documentation, and audits

• Adhere with cGMP requirements along with general safety policies

Qualifications of the Quality Person in Plant (QPIP):

• Bachelor’s Degree in Engineering or Science; or 10+ years of related experience required

• Strong background in compliance with cGMP regulations along with FDA/EU related to manufacturing of products related to cells

• Experience in an aseptic manufacturing environment, QA, cell therapy, or clinical quality required

• 3 years’ experience working in QA on the manufacturing/shop floor

Compensation for the Quality Person in Plant (QPIP):

• $80,000 - $90,000

• Full-time, permanent

• Comprehensive Medical benefits: Medical, Dental, Vision, 401K

Keywords: Quality, QA, Quality Manufacturing, Pharmaceutical Manufacturing, QPIP, cGMP, QC, Cell therapy, Clinical quality, Aseptic, T-cell, (CAR) T-cell therapy, non-conformances, ISO 5, FDA, EU, Compliance, CAPAs, Bio Tech, Raritan, Shop floor, Line Clearance, Batch record review, Biotech, Real-time