Qualifications:
1. A BA/BS degree or equivalent experience is preferred.2. 1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required.
Responsibilities:
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. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation. Some physical movement of document files/boxes is required; must be able to lift 30 pounds
1. Distribute approved documentation to appropriate personnel, track receipt of documentation, reconciliation and maintain distribution matrices.2. Assist in the maintenance of hard copy and electronic document files.3. Label and code files for storage in on-site Documentation Centers.4. Assist in the administration of the company GMP Records Retention Policy, including document imaging and preparing documents for shipment to off-site storage.5. 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.7. Ensure ethics and compliance commitment at all times. Report/Address compliance issues in a timely manner. Attend cGMP training programs as required.
