Job Description
· Assemble, catalogue, preserve, and manage site-wide material, including study data and equipment records
· 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
· Knowledge of regulatory requirements; GLP, GCP, OECD, 21Part 11
· 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 to 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 process and procedures
· Other tasks as assigned
Skills, Qualifications & Education
· BA/BS or higher; all experiences will be evaluated
· Able to perform archiving tasks
· Able to work in a regulated environment
· Able to work effectively and contribute within a team
· Able to work with computer systems
· Able to document and communicate clearly; Knowledge of and experience in a regulatory environment
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