Senior Associate, Document Control

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.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.