Assistant Document Control

Assistant Document Control needs 1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industry

• BA/BS degree or equivalent experience is preferred.
• 1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required.
• Strong computer applications in the Microsoft Office Suite
• Document scanning
• Assist in the distribution, reconciliation, labeling and filing of GMP documentation.
• Update and maintain document tracking databases and archival systems.
• Assist in Documentation Audit programs for GMP documents.
• Some physical movement of document files/boxes is required; must be able to lift 30 pounds
• Distribute approved documentation to appropriate personnel, track receipt of documentation, reconciliation and maintain distribution matrices.
• Assist in the maintenance of hard copy and electronic document files.
• Label and code files for storage in on-site Documentation Centers.
• Assist in the administration of the company GMP Records Retention Policy, including document imaging and preparing documents for shipment to off-site storage.
• Data Entry of batch record data into qualified database.
  6. Initiate and track periodic Documentation Binder Audits to assure documentation in the field is current and complete.
• Ensure ethics and compliance commitment at all times.
• Report/Address compliance issues in a timely manner. Attend cGMP training programs as required.