GMP Operational Quality Sr Specialist

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JMD Technologies Inc. provided pay range This range is provided by JMD Technologies Inc..

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Base pay range $55.00/hr - $60.00/hr Direct message the job poster from JMD Technologies Inc.

Title GMP Operational Quality Senior Specialist Employment Type Contract (6+ months) Status Accepting Candidates About the Role Join a QA team in the Cell & Gene Therapy space providing GMP operational support across clinical and commercial manufacturing.

This role ensures quality oversight, product disposition, and compliance while supporting cross-functional teams in a high-throughput environment.

Key Responsibilities QA operational support for GMP manufacturing (clinical & commercial drug product) Batch record review, batch disposition, and QA data review Deviations, investigations, CAPAs, OOS/OOT management Quality on the Floor support, walkthroughs, and manufacturing document review Support product release, COAs, change controls, and inspection readiness Cross-functional collaboration with Manufacturing, QC, Engineering, and Supply Chain Participate in process improvements and inspection readiness initiatives Provide guidance for product complaints, recalls, and compliance gaps Qualifications Strong QA Operations background in a GMP environment Experience with batch record review, batch disposition, or product release Hands‑on experience with deviations, investigations, CAPAs, and OOS/OOT Exposure to Cell & Gene Therapy or ATMP manufacturing preferred Knowledge of GMP, aseptic processing, and CMC regulatory requirements Experience with TrackWise, Oracle, or similar QA/ERP systems Master’s degree with 2–3 years relevant experience, or Bachelor’s degree with 3–5 years experience Comfortable working fully onsite and supporting production floor activities Demonstrated success leading cross‑functional teams Compensation (MA Pay Transparency) Estimated hourly range

$55–$60/hr (W‑2) Final rate within this range will be based on skills, experience, and interview results Seniority level Mid‑Senior level Employment type Contract Job function Quality Assurance Industries IT Services and IT Consulting Get notified about new Operational Specialist jobs in Boston, MA . #J-18808-Ljbffr