Senior Associate, Document Control

Company: Alnylam Pharmaceuticals

Overview

Reporting to the site Document Control Manager the Sr. QA Document Control & Records Management Associate will support Alnylam’s internal manufacturing sites with all document control related processes, records management, & inspections and audits.

This is an on-site position primarily located at the Norton, MA site with periodic support at the Alewife-Cambridge, MA site.

Key Responsibilities:

Document Control:

• Coordinate and independently process internal documentation including SOP’s, Work Instructions, forms, e-forms, master batch records, methods, etc.
• Develop subject matter expertise on the electronic document management system (eDoc) and provide support for system and processing improvements.
• Provide document authoring and eDoc support to users.
• Issue batch records and logbooks to meet site timelines.
• Conduct controlled copy issuance, reconciliation and quarterly monitoring.
• Assist with metrics reporting.
• Enhance Document Control SOP’s and supporting documents in accordance with corporate and regulatory requirements.
• Support document processing for Alewife manufacturing site as needed.

Record Retention:

• Scan and process executed batch records into eDocs then archive accordingly.
• Conduct logbook surveillance to meet archive requirements.
• Maintain controlled records receipt, inventory, and archive.
• Serve as site expert for archiving questions and issues.
• Support site manufacturing compliance with Record Retention Program.
• Provide expedient retrieval of records for site audits, inspections and related activity as required.
• Support various roles during audits/and inspections, i.e. back room/front room support.
• Support process improvements while ensuring continued compliance.
• Provide support to the Alewife Manufacturing site including on site as needed.
• Other duties as assigned by the Document Control Manager.

Qualifications:

• Bachelor’s Degree (BA/BS) in life sciences or related field;
• 2+ yrs. experience in document management, preferably in FDA regulated environment.

Or

• 4+ yrs. experience in document management in an FDA regulated environment without a degree.
• eDMS experience required (Veeva) preferred.
• Strong understanding of Document and Records Control GxP Regulatory Requirements preferred.
• Proficiency in Microsoft Office required and Adobe preferred.
• Written and oral communication skills required.
• Excellent eye for detail required.
• Strong interpersonal and organizational skills required.
• Self-directed required.
• Periodic travel to Cambridge required.