BioSpace · 2 days ago

Senior Specialist, Quality GMP

Boston, MA

Contract

Onsite

Senior Level

5+ years exp

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Comp. & Benefits

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Responsibilities

Review and approve Master and Executed Batch Records.

Review in-process, release, and stability data.

Disposition lots from intermediates through finished drug product.

Support internal and external deviations, change control, and CAPA.

Support Vendor Management Program, including management of vendor audit activities and the Approved Supplier List.

Write and implement changes to Standard Operating Procedures.

Coordinate and review change control activities to drive change control records to closure.

Deliver expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records.

Perform the appropriate QA review/approval of SOPs, SOP-related documents, and Policies.

Lead and support understanding and adoption of risk-based approaches and decision making.

Serve as Quality resource, representing QA on teams in support of assignments.

Interact on cross-functional teams including manufacturing and QC.

Support all GxP functions as needed.

Qualification

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ChemistryBiologyScientific FieldGMPCMCQASOP AuthoringSOP ReviewingBoston AreaOffice AttendanceAttention to DetailCommunicationCollaborationMethod ValidationQC Support