Specialist, QA OTF

Position Summary

We have an opportunity for a Specialist, QA OTF to join our team supporting GMP manufacturing of master and working cell banks, biological bulk drug substances, and finished drug products for human use. The role provides real-time quality oversight, documentation review, deviation management, and compliance monitoring to ensure product quality and patient safety. The Specialist will work closely with manufacturing and support teams to maintain high standards of GMP compliance and continuous improvement. This position reports to the Manager, QA.

Shift: Monday - Friday, 8am - 5pm. Location: Princeton, NJ 100% Onsite.

The Role

• Partner with Manufacturing and cross-functional teams, maintaining a strong floor presence (approximately 80%) to support GMP operations and ensure real-time quality oversight.
• Perform QA on-the-floor activities, including room release, observation of critical manufacturing processes, issue resolution, and real-time batch record review.
• Conduct routine audits and walkthroughs of manufacturing, warehouse, and support areas to verify compliance, equipment readiness, material control, labeling, and housekeeping standards.
• Monitor adherence to cGMP requirements, Quality Management System procedures, aseptic behaviors, and Good Documentation Practices.
• Review manufacturing documentation and batch records for accuracy, compliance, and contemporaneous completion using controlled documents.
• Provide QA oversight for the manufacture of cell banks, drug substances, and final drug products, including Acceptable Quality Limit (AQL) visual inspections.
• Make independent quality decisions, identify risks, escalate issues appropriately, and drive continuous improvement initiatives.
• Serve as a quality resource to GMP personnel by providing guidance on compliance, regulatory requirements, internal procedures, and industry best practices.
• Build effective partnerships across operations and support functions to strengthen quality culture and operational excellence.
• Ensure timely completion of projects, documentation, and quality deliverables while maintaining professionalism and effectiveness in a dynamic team environment.

The Candidate

Minimum Requirements

• High school diploma or General Educational Development required; Bachelor's degree preferred.
• 2+ years of experience within the biologic, biopharmaceutical, or regulated industry.
• Knowledge or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
• Strong knowledge of Good Manufacturing Practices, 21 CFR Parts 210 and 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
• Creative and adaptable professional with strong troubleshooting, decision-making, and communication skills; able to quickly learn new manufacturing processes, interpret evolving global regulations, and deliver results independently or collaboratively in fast-paced GMP environments while effectively engaging personnel at all levels, including regulatory inspectors.
• Ability to work extended periods while standing or sitting in Grade B gowning, perform documentation and computer-based tasks, and meet required visual acuity and color vision standards.
• Capable of handling physical demands including lifting or pushing up to 50 lbs., working in confined spaces, and performing cleaning activities using disinfectants, sporicidal agents, and specialized equipment.
• Comfortable working in GMP manufacturing environments with exposure to human blood components, biohazardous materials, moving mechanical equipment, and other controlled operational hazards.
• Work performed in grade A BSC or grade B, C, or D controlled environments with full gowning requirements and aseptic techniques.

Preferred Skills & Background

• 1+ years of experience in Manufacturing, Quality Assurance, or Quality Control preferred.
• Knowledge of pharmaceutical regulations relating to biologics preferred.
• Experience or knowledge in Trackwise preferred.
• Experience or knowledge with electronic batch records preferred.