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Job description
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JMD Technologies Inc. provided pay range
This range is provided by JMD Technologies Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
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
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Worksite address
boston, MA, 02298, US
Who can apply
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