The Archivist is responsible for the controlled management, preservation, security, traceability, and retrieval of regulated study and facility records throughout their archival lifecycle. The role ensures archived materials are complete, accurately inventoried, appropriately maintained, readily retrievable, and managed in accordance with applicable regulatory requirements, Good Documentation Practices (GDP), company SOPs, and client requirements.
As a key component of the site's quality and compliance infrastructure, the Archivist maintains chain of custody and access controls, supports controlled transfer and retrieval of records, monitors archive conditions, and ensures the archive remains continuously organized and inspection ready. The Archivist also supports client and regulatory inspections, partners with operational and quality teams to resolve archival deficiencies, and contributes to the continuous improvement of records-management processes and procedures.
- This position requires a strong sense of ownership, accuracy, integrity, and accountability, recognizing that effective archival management is essential to protecting the integrity, availability, traceability, and long-term preservation of regulated records.
- Previous experience in records management, document control, archiving, quality, laboratory operations, or another documentation-intensive environment preferred.
- Experience working within a regulated environment, preferably pharmaceutical, biotechnology, CRO, clinical, or laboratory operations.
- Working knowledge of applicable regulatory and quality requirements, such as GLP, GCP, OECD requirements, 21 CFR Part 11, and Good Documentation Practices (GDP), or demonstrated ability to develop this knowledge.
- Strong attention to detail with the ability to accurately inventory, catalogue, track, retrieve, and reconcile controlled records and materials.
- Ability to maintain appropriate document traceability, chain of custody, security, confidentiality, and access controls for archived materials.
- Strong organizational and time-management skills with the ability to manage multiple priorities and maintain an archive in a state of continuous inspection readiness.
- Proficiency with computerized systems and electronic records-management tools; experience with document management systems, electronic archives, LIMS, or similar regulated systems is preferred.
- Ability to identify documentation discrepancies, assess potential compliance risks, and appropriately communicate or escalate issues requiring resolution.
- Ability to follow established SOPs and work independently while exercising sound judgment within defined procedures and regulatory requirements.
- Strong written and verbal communication skills, including the ability to document activities clearly, accurately, and contemporaneously.
- Demonstrated ability to work effectively and collaboratively with cross-functional teams, including Quality Assurance, laboratory operations, Study Management, Facilities, and other site functions.
- Ability to support client, internal quality, and regulatory inspections involving archived records and associated documentation.
- High level of integrity, accountability, discretion, and ownership when managing regulated and confidential records.
Bachelor's degree (BA/BS) in a scientific, records management, information management, business, or related discipline preferred; equivalent education and relevant professional experience will be considered.
Previous experience in records management, document control, archiving, quality, laboratory operations, or another documentation-intensive environment preferred.