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Records Management Specialist

Planet Pharma
Marlborough, MA Full Time
POSTED ON 3/24/2025 CLOSED ON 4/10/2025

What are the responsibilities and job description for the Records Management Specialist position at Planet Pharma?

Job 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 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.

Pay Rate Range: $20-35/hr depending on experience
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Salary : $20 - $35

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