Quality Operations Specialist

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

Position Summary

The Quality Operations professional provides hands-on Quality Assurance oversight and support for GMP-regulated clinical manufacturing and technical operations, ensuring compliance with applicable cGMP requirements, regulatory expectations, and company quality standards. This role is responsible for on-floor quality support, GMP documentation review and approval, batch record

Key Responsibilities

• Provide on-floor Quality Operations (QO) 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 (e.g., batch records, SOPs, test methods, validation protocols, 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.
• Ensure timely resolution and escalation of quality issues to support lot closure and product release.
• Lead and drive investigations into deviations, non-conformances, environmental excursions, and process anomalies.
• Review and approve deviations and CAPAs, ensuring robust, timely, and compliant resolution.
• Apply structured root cause analysis tools such as 5 Whys, Fishbone (Ishikawa), FMEA, and other risk-based approaches to support investigations and ensure thorough, compliant, and timely investigations.
• Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams to resolve quality issues.
• Represent the Quality Operations department in team discussions and project meetings.
• Keep management informed of progress, issues, and needs to ensure smooth execution of GMP Operations and quality-related activities.
• Partner with internal stakeholders and external customers to address quality concerns and propose compliant, risk-based solutions.
• Support continuous improvement initiatives to enhance quality, compliance, and operational efficiency.
• Participate in and support internal audits, facility walkthroughs, and regulatory inspections.
• Proactively notify management of risks, identify and help implement process improvements based on root cause trends and investigation outcomes.
• Perform additional duties as required to support departmental goals.

Required Qualifications

• Bachelor’s degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry.
• 3-5 years of QA experience in a GMP-regulated environment, ideally with cell therapy, gene therapy, or other advanced biologics; CDMO experience strongly preferred
• Strong knowledge of batch record review, aseptic operations, and environmental monitoring and cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA