Quality Assurance Specialist II

Job Summary The Quality Specialist II is a global Quality Assurance role reporting to the Director of Quality Assurance. This position is responsible for supporting product release and key Quality Management System (QMS) processes, including deviations, nonconformances (NCM), CAPA, complaints, and change control, for the Plain City, Ohio, US, manufacturing site and the Redcar, UK, site. This is a hybrid role with an on-site expectation of 4 days per week in Plain City, OH , and requires early hours some days to support Quality Operations at the UK site. The position manages quality events from initiation through closure (e.g., deviations, nonconformances, CAPAs, and escalated complaints), including investigation support, facilitation of root cause analysis, and verification of the effectiveness of corrective and preventive actions. The role also performs batch record reviews for product release and provides hands‑on support for other QMS activities at the Plain City, OH site, while coordinating remotely with the UK site. Responsibilities Review batch records and approve product release in the ERP system (NetSuite) in accordance with established procedures. Own and track deviations, nonconformances (NCM), and complaint investigations from initiation to closure, including coordinating root cause analysis and ensuring timely, effective CAPA implementation. Support change control by partnering with operational teams to initiate change requests, perform risk/impact assessment, and coordinate stakeholder reviews through implementation and closure. Administer the electronic QMS (Dot Compliance), including user administration, workflow configuration support, and day‑to‑day system troubleshooting for the Ohio and UK sites. Maintain controlled quality records, ensuring accurate filing, version control, retention, and retrieval in accordance with record control requirements. Compile, trend, and report monthly QMS metrics using Excel logs and eQMS data; escalate adverse trends and recommend improvement actions. Support quality improvement initiatives by developing action plans, tracking deliverables, communicating status, and driving timely completion of agreed actions. Prepare for and support customer, internal, and certification audits, including hosting audit activities, coordinating responses, and tracking corrective actions to closure. Promote a strong quality culture by supporting QMS training, coaching cross‑functional partners on process requirements, and reinforcing compliance expectations. Perform other duties as assigned to support the Quality Assurance function. Job Qualifications (Experience, Education, Knowledge, and Skills) Required minimum of 2 years of direct experience in Quality Assurance supporting Deviation /NCM /Change Control and CAPAs. Required strong knowledge of ISO 9001 requirements. Required minimum BS Degree in Bioscience/ Chemistry or similar science discipline. Preferred experience with NetSuite ERP and managing eQMS software. e.g. DOT Compliance etc. Preferred ISO 9001: 2015 or ISO 13485: 2016 certified auditor. Strong organizational skills and ability to support multiple quality projects simultaneously. Excellent verbal and written communication skills. Competencies Identified for Success Passionate About Problem‑Solving: Concerned about identifying inefficiencies, analyzing root causes, and recommending effective solutions. Work Independently and as Part of a Team: Collaborate across teams, including engineering, production, QC, product development, and customer service, contributing to risk analysis and QMS guidance. Proactive and Personable: Initiate communication and build strong relationships with colleagues to support QMS implementation. Project Coordination: Track multiple quality metrics and provide timely updates. Credible: Serve as a role model of the ISO 9001 Principle: “Say what you do and do what you say.” The anticipated salary range for this position is $65,488 – $72,765. The salary offer will depend on multiple factors, including the successful candidate's skills, experience, and other qualifications. #J-18808-Ljbffr