GMP Operational Quality Sr Specialist

JMD Technologies Inc.; Boston (MA); On-site; USD 75,768 - 82,656; Part time

Job summary

A leading firm in IT Services and Consulting is seeking a GMP Operational Quality Senior Specialist in Boston, MA. The role includes providing quality oversight and operational support for GMP manufacturing, requiring a strong background in QA operations and experience in batch record reviews. Ideal candidates should have relevant educational qualifications and be comfortable in a dynamic, onsite environment. Competitive pay range is offered based on experience.

Qualifications

• Strong QA Operations background in a GMP environment.
• Experience with batch record review and product release.
• Comfortable working fully onsite.

Responsibilities

• Provide QA operational support for GMP manufacturing.
• Conduct batch record review and QA data review.
• Support product release and inspection readiness.

Skills

Strong QA Operations background in a GMP environment

Experience with batch record review

Hands-on experience with deviations, investigations, CAPAs

Knowledge of GMP and aseptic processing

Experience with TrackWise or Oracle

Demonstrated success leading cross-functional teams

Education

Master’s degree with 2-3 years relevant experience

Bachelor’s degree with 3-5 years experience

Tools

TrackWise

Oracle

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

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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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