Quality Assurance Specialist

Piper Companies is hiring a Quality Assurance Specialist to provide support for clinical laboratory and manufacturing activities at a 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.

Responsibilities of the Quality Assurance Specialist Include:

• 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.

Qualifications for the Quality Assurance Specialist Include:

• 2–4 years of relevant experience in Quality Assurance within a GMP-regulated environment.
• Prior experience in cell or gene therapy, or biologics, is desirable.
• Solid knowledge of cGMP principles and biopharmaceutical regulatory requirements.
• Bachelor’s or Master’s degree in a life science, technical field, or engineering discipline.

Compensation for the Quality Assurance Specialist Includes:

• Hourly Rate: $46-48/HR *depending on experience*
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, and additional benefits aligned with company policy.

Keywords:

Quality Assurance Operations, GMP Compliance, Batch Record Review, Raw Material Release, Document Control, SOP Revision, Biologics QA, Cell Therapy QA, cGMP Regulations, QA Specialist, Quality Documentation, Manufacturing QA Support, QA in Biopharma, QA in Cell Therapy, QA Protocol Review, QA Policy Approval, QA Document Archiving, QA Label Issuance, QA Logbook Management, QA in Clinical Manufacturing, QA in Oncology Therapeutics, QA in iPSC Technology, QA in Allogeneic Cell Therapy, QA in Regenerative Medicine, QA in Immunotherapy, QA in Stem Cell Therapy, QA in Biotech Startups, QA in NJ Biotech, QA Specialist Branchburg NJ, QA in Century Therapeutics, QA in Fast-Paced Environments, QA Cross-Functional Collaboration, QA Communication Skills, QA Attention to Detail, QA in Quality Systems, QA in Controlled Documentation, QA in Biotech Manufacturing, QA in QA Operations, QA in QA Records Management

This position opens for applications on 10/21/2025. Applications will be accepted for at least 30 days from the posting date.

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