Records Management Specialist

Job Title: Records Management Specialist

Job Location: Marlborough, MA 01752

Job Duration: 6 Months

Job Description:

The Records Management Specialist will play a crucial role in organizing, maintaining, and ensuring the management of GxP documentation to support compliance and operational efficiency.

Key Responsibilities:

• Organization & Classification: Develop, implement, and maintain an organized filing system for on-site records and documentation, ensuring easy accessibility, compliance, and consistency with established guidelines and procedures.
• Off-Site Record Management: Prepare and itemize eligible records for off-site storage, ensuring that documentation is processed in accordance with the Client corporate Records Retention Schedule. Coordinate the logistics of box pick-up and retrieval for off site records, ensuring timely and accurate pick-up and retrieval.
• Documentation Discrepancy Resolution: Assist with investigating discrepancies related to missing or misplaced documentation.
• Scanning & Electronic Documentation Management: Scan executed documentation into validated Electronic Document Management System (EDMS) (Veeva), ensuring proper indexing and categorization.
• Document Issuance & Reconciliation Support: Assist with the issuance and reconciliation of GxP documentation, as needed.
• Document Control Support: Provide assistance with document control-related activities, including procedure creation and revision, as needed.

Required Qualifications:

• AS degree and 4 years of experience or BS degree and 2 years of experience in records management, document control, archiving, or a related role within a regulated industry. Experience in life sciences or similar field is preferred.
• Strong understanding of records retention policies, procedures, and best practices. Proficiency in managing off-site storage logistics and compliance with corporate Records Retention Schedules.
• Familiarity with Good Documentation Practices (GDP) and ALCOA principles to ensure compliance with industry standards for recordkeeping and documentation.
• Exceptional attention to detail, with strong organizational and multitasking abilities.
• Ability to manage multiple priorities while maintaining accuracy and efficiency.
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
• Proficiency with Document Management Systems, with experience in Veeva or similar platforms strongly preferred. Advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to lift and move record boxes, as required, for storage and shipment (up to 25 50 pounds).

Preferred Qualifications:

• Experience supporting audits, inspections, or other regulatory compliance activities is a plus, with an understanding of how records management supports organizational audit readiness