Quality Assurance Specialist

ZP Group•Branchburg, NJ

56d•$46 - $48•Onsite

About The Position

Piper Companies is hiring a Quality Assurance Specialist to provide support for clinical laboratory and manufacturing activities at its GMP site in Branchburg, New Jersey. This position is essential for maintaining adherence to cGMP requirements, streamlining documentation processes, and ensuring robust quality oversight for raw material release and batch record review.

Requirements

2-4 years of relevant experience in Quality Assurance within a GMP-regulated environment.
Solid knowledge of cGMP principles and biopharmaceutical regulatory requirements.
Bachelor's or Master's degree in a life science, technical field, or engineering discipline.

Nice To Haves

Prior experience in cell or gene therapy, or biologics, is desirable.

Responsibilities

Oversee GMP documentation processes, including creation, routing, tracking, archiving, and issuance of controlled records such as logbooks and labels.
Review and verify executed batch records for compliance with approved procedures, resolving discrepancies with manufacturing teams.
Manage raw material release and ensure adherence to established quality standards.
Maintain and update Standard Operating Procedures (SOPs) to reflect current practices and regulatory requirements.
Perform document control review and approval for protocols, reports, policies, and other QA documentation.