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Documentation Specialist II

  • Unicon Pharma
  • 09/07/23
  • Framingham, MA
  • 01701
  • 30.00 / Hourly
  • Full-Time
Job Title:Documentation Specialist II
Location: Framingham, MA 01701
Duration: 10+ months-Contract
100% onsite role
Job Description:
Records Management ensures that cGMP records used at Framingham are managed and protected during their life-cycle (issuance, reconciliation, archival and destruction) in compliance with business needs and regulatory expectations. The overall goal is to ensure that record management policies, procedures, and processes meet applicable regulations. Additionally, record management provides life-cycle guidance to records users.
Position Summary:
The Record Management Specialist is responsible providing Record Management related quality support and guidance to ensure continued compliance to cGMP and company expectations.

Core Responsibilities
Perform record issuance and reconciliation activities.
Interact/update/maintain the record management database.
Initiate/perform periodic record audits.
Point of contact for customer record management discussions.
Point of contact for record off-site storage and retrieval.
Interact/update offsite records management vendor database.
Assist with record destruction.

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

Employer Information

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