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Compliance Specialist I
Ref No.: 15-03881
Location: Northborough, Massachusetts
Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulations. Gain understanding of new Northborough facility process flows and author operational SOPs as required. May review manufacturing batch production records or site logs adhering to Genzyme SOPs and quality standards in accordance with FDA and GMP requirements.

May compile required GMP documentation supporting finished product lot release. May assist with deviation investigation reports. Interprets complex, explicit documentation to ensure quality standards and compliance. May process lots for shipment to other Genzyme sites and pulls retention samples. Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contributes to the completion of organizational projects and goals as required. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.

May require travel to other Genzyme locations such as Westbourough or Framingham.

Skills:
Experience in GMP environment preferred.
Education: BS degree (Science preferred).