Archivist (life sciences)

About the Role

This role involves assembling, cataloguing, preserving, and managing site-wide material, including study data and equipment records. The position requires maintaining a chain of custody and inventory of archived material, verifying items for traceability, and ensuring compliance with regulatory requirements such as GLP, GCP, OECD, and 21 CFR Part 11.

Responsibilities

• Retrieve requested information as required
• Maintain chain of custody and inventory of archived material
• Verify items submitted and returned are properly captured on documents for traceability
• Follow applicable SOPs and procedural documents
• Coordinate with QA and management to ensure all SOPs are reviewed and approved in a timely manner
• Ensure Archives is clean and inspection ready at all times
• Record tasks in accordance with Good Documentation Practices (GDP)
• Monitor Archives environmental conditions for proper preservation of material
• Review, update, or author SOPs as required
• Assist with client and regulatory audits as applicable
• Train others on archiving processes and procedures
• Perform other tasks as assigned

Qualifications

• BA/BS or higher; all experiences will be evaluated
• Knowledge of regulatory requirements: GLP, GCP, OECD, 21 CFR Part 11

Skills

• Able to perform archiving tasks
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Proficient with computer systems
• Able to document and communicate clearly
• Knowledge of and experience in a regulatory environment