Document Control and Records Management Specialist
RoslinCT US•Hopkinton, MA
•$52,000 - $76,000•Onsite
About The Position
The Document Control and Records Management Specialist position is responsible for supporting the implementation of the Document Control Program and Records Management programs through timely archival and retrieval of controlled documents. This role may also support logbook and protocol issuance processes.
Requirements
- Effective problem-solving capabilities.
- Strong oral and written communication skills.
- A highly organized work style that ensures timely execution of tasks.
- A mindset that ensures accurate results.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- 0-2+ years working in a regulated GMP environment
- Ability to work independently to meet objectives and timelines
- Experience in Adobe, Microsoft Excel, and Microsoft Word
Nice To Haves
- Prior experience in document control and records management a plus
- Experience in 21 CFR Part 210/211 and 21 CFR Part 11; familiar with ICH regulations/ guidelines a plus
Responsibilities
- Support record scanning and archival functions in compliance with site procedures
- Prepare documents for off-site storage
- Support verification of true copies/scans
- Preparation and maintenance of document templates
- Maintenance of the site glossary
- Maintain document inventory logs
- Support logbook issuance and reconciliation
- Support corrective actions and program enhancements as assigned
- Support document retrieval for regulatory inspections and client audits
Benefits
- medical
- dental
- vision insurance
- educational assistance
- a 401(k) program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
