Job Title: Quality Specialist

We are seeking a dedicated Quality Specialist to join our dynamic team within a rapidly growing Cell and Gene Therapy CDMO at a brand new site. In this role, you will ensure compliance with quality objectives and regulatory requirements while supporting manufacturing and technical operations.

• Provide on-floor Quality Operations support for manufacturing, warehouse, and other technical operations, including in-process checks, deviation identification, and adherence to cGMP expectations.
• Ensure all manufacturing activities comply with GMP and regulatory requirements.
• Review and approve GMP documentation such as batch records, SOPs, test methods, validation protocols, and technical reports for accuracy and compliance.
• Execute product-related activities, including apheresis material receipt, raw material disposition, production document issuance, batch review, and final product disposition and shipment.
• Lead and drive investigations into deviations, non-conformances, environmental excursions, and process anomalies.
• Apply structured root cause analysis tools such as 5 Whys, Fishbone (Ishikawa), and FMEA to support investigations.
• Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams to resolve quality issues.
• Support continuous improvement initiatives to enhance quality, compliance, and operational efficiency.
• Participate in and support internal audits, facility walkthroughs, and regulatory inspections.

• 3+ years of cell therapy experience.
• 3-5 years of GMP manufacturing experience.
• Experience in Quality Assurance oversight for manufacturing floors.
• Proficient in ISO 7 gowning procedures.
• Bachelor’s degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry.
• 5-7 years of QA experience in a GMP-regulated environment, ideally with cell therapy, gene therapy, or other advanced biologics.
• Strong knowledge of batch record review, aseptic operations, and environmental monitoring.
• Demonstrated ability to lead and close complex quality investigations including root cause analysis and development of effective CAPAs.

• CDMO experience is strongly preferred.
• Strong knowledge of cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA guidance.
• Proficient in investigation tools and methodologies such as Fishbone diagrams, 5 Whys, and FMEA.
• Excellent problem-solving skills with a focus on risk-based decision-making and continuous improvement.
• Ability to understand technical concepts and make informed quality decisions in clinical manufacturing.
• Willingness to work in ISO 7 environments for on-the-floor QA support.
• Proactive, adaptable, and committed to continuous learning.
• Flexibility to travel between facilities and work varying hours, including evenings, weekends, and shifts as needed.

Work at a growing CDMO specializing in Cell and Gene Therapy at a brand new site. This position requires working in ISO 7 environments and may involve varying work hours, including evenings, weekends, and shifts. The role involves being actively present on the manufacturing floor, supporting operational excellence and contributing to a collaborative team-oriented environment.

This is a Permanent position based out of NA, New Jersey.