Alturas Analytics, Inc. needs an Archivist to manage and preserve scientific data, ensuring compliance with Good Laboratory Practices (GLP) regulations and Standard Operating Procedures (SOPs). This role is crucial for maintaining the integrity of laboratory documentation, supporting audits, and facilitating efficient access to archived materials for research and regulatory purposes.
Requirements
- Basic data entry, filing, indexing, scanning, and retrieval of active physical documents according to Standard Operating Procedures and applicable FDA regulations and guidelines.
- Assist in maintaining workflows and procedures in an electronic document management system (e.g., TMS - test method updates).
- Assist with tracking document movement and status.
- Assist in developing technical procedures related to work processes in the Document Management Department.
- Provide document retrieval support to the Quality Assurance Unit and other appropriate staff during client and regulatory audits.
- Handle documents in a confidential manner, adhering to company privacy and security guidelines.
Responsibilities
- Organize, catalog, and archive laboratory records, study data, reports, and related documentation in accordance with GLP guidelines and organizational policies.
- Ensure proper metadata, indexing, and secure storage of physical and electronic records to maintain traceability and confidentiality.
- Manage the archiving process, including the transfer of data from active studies to long-term storage systems.
- Verify the completeness and accuracy of archived materials, ensuring compliance with FDA regulatory requirements.
- Retrieve and provide access to archived records as needed for internal reviews, regulatory audits, or legal inquiries.
- Maintain and update archiving databases and systems to track the location and status of stored materials.
- Collaborate with Quality Assurance and laboratory teams to resolve discrepancies or issues related to archived records.
Other
- This position is on-site in Moscow, Idaho.
- Are you passionate about organization and precision?
- If you thrive in a detail driven environment and love keeping things running smoothly, wed love to hear from you!
- Communicate with clients to return or dispose of archived materials that have met retention timelines.
- Stay current with GLP regulations and industry best practices to ensure ongoing compliance.
