Duties:
- MBR Preparation & Scanning:
- Receive, review, and prepare MBRs for scanning (verify completeness, paginate, remove staples, repair pages as needed).
- Operate scanning equipment to digitize MBRs at required resolution and format (e.g., searchable PDF), ensuring zero page loss and high image quality.
- Maintain standardized file naming and folder structures to enable rapid retrieval and audit readiness.
- Records Control & Retrieval:
- Manage secure storage and access permissions for scanned and physical MBRs.
- Respond to internal requests (Quality, Manufacturing, Supply Chain, Engineering) by locating, retrieving, and providing MBRs.
- Track requests, turnaround times, and document issuance/return to maintain chain-of-custody.
- Compliance & Data Integrity:
- Adhere to GxP, GDP (Good Documentation Practices), and company SOPs at all times.
- Conduct routine self-checks and peer reviews to ensure accuracy, completeness, and traceability.
- Support audits/inspections by preparing document packs, access lists, and evidence of control.
- Physical & Inventory Controls:
- Maintain organized physical archives; perform periodic inventory and reconciliation of records.
Working Hours: M-F 8:AM - 5:00PM CST