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.
location: Westborough, Massachusetts
job type: Contract
salary: $35 - 45 per hour
work hours: 9 to 5
education: Bachelors
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 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.
qualifications:
Required:
- At least a AS degree and 4+ years of experience in records management, document control, archiving, or a related role within a regulated industry.
- Would also accept a BS degree and 2+ years of experience in records management, document control, archiving, or a related role within a regulated industry.
- Strong understanding of records retention policies, procedures, and best practices.
- Proficiency in managing off-site storage logistics
- Proficiency in compliance with corporate Records Retention Schedules.
- Familiarity with Good Documentation Practices (GDP) and ALCOA+ principles. documentation.
- Proficiency with Document Management Systems.
- Prior experience in life sciences or similar field is preferred.
- Prior experience supporting audits, inspections, or other regulatory compliance activities
- An understanding of how records management supports organizational audit readiness.
- Experience in Veeva or similar platforms.
skills: MS-WORD, MS-EXCEL, MS-Powerpoint
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
