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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
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.