Records Management Specialist

Title : Records Management Specialist

Duration : 06+ Months (Possible Extension)

Location : Marlborough, MA 01752

Pay rate : up to $40 / hourly on W2

Description :

Position Overview : 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 Astellas corporate Records Retention Schedule. Coordinate the logistics of box pick-up and retrieval for offsite 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.