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Compliance Specialist I
Ref No.: 15-03807
Location: Allston, Massachusetts
Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation. Establishes auditing requirements, quality standards and test methods in accordance with FDA and GMP requirements. Conducts internal audits of manufacturing processes to ensure compliance. Conducts review of testing results. Reviews document and completes inspection of returned goods. Interprets complex, explicit documentation to ensure quality standards and compliance. May provide training to new employees. Works under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify. Frequent internal company and external contacts. Represents organization on specific projects.

Skills:
Prior experience reviewing production batch records in a GMP facility.
Must be familar with good documentation and manufacturing practices Prior experience reviewing Quality Control data in a GMP facility.
Must be able to enter classified areas and gown appropriately.
Must be able to work in bulk manufacturing areas during shift hours.
Must be detailed oriented.

Education:
High school degree or higher.