Quality Specialist Position Available In Mercer, New Jersey

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Quality Specialist Job Description We are seeking a dedicated Quality Specialist to ensure compliance with quality objectives and regulatory requirements. This role involves providing on-floor Quality Operations support and overseeing various quality-related activities to maintain the highest standards in manufacturing, warehouse, and technical operations. Responsibilities Provide on-floor Quality Operations (QO) support, including in-process checks and deviation identification. Ensure all manufacturing activities comply with GMP and regulatory requirements. Review and approve GMP documentation, such as batch records, SOPs, and validation protocols. Execute product-related activities, including material receipt, raw material disposition, and final product disposition. Lead investigations into deviations, non-conformances, and process anomalies. 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 internal audits, facility walkthroughs, and regulatory inspections. Essential Skills 3+ years of cell therapy experience. 3-5 years of GMP manufacturing experience. Bachelor’s degree in a relevant scientific discipline. 5-7 years of QA experience in a GMP-regulated environment. Strong knowledge of batch record review, aseptic operations, and cGMP regulations. Proficient in investigation tools such as Fishbone diagrams and 5 Whys. Excellent problem-solving skills with a focus on risk-based decision-making. Additional Skills & Qualifications CDMO experience strongly preferred. Strong knowledge of quality and risk management principles. Ability to understand technical concepts and make informed quality decisions. Willingness to work in ISO 7 environments. Proactive, adaptable, and committed to continuous learning. Flexibility to travel between facilities and work varying hours. Work Environment This role is based in a growing CDMO specializing in Cell/Gene Therapy, located at a brand new site. The work environment involves being on the manufacturing floor, requiring ISO 7 gowning, and engaging in collaborative problem-solving with various teams. Flexibility in working hours, including evenings and weekends, is expected.