As a part of the Quality Assurance team, the Archivist promotes and supports a culture of audit readiness within ACM Global Laboratories. Responsible for managing archiving system for ACM Global Laboratories through standardized processes and controls for document retrieval, cataloging, storage and monitoring. The Archivist is based in our Rochester, NY site and reports to the Supervisor, Document Control.
STATUS: Full Time
LOCATION: 160 Elmgrove Road, Rochester NY
DEPARTMENT: Quality Assurance
SCHEDULE: Monday – Friday
- Associate’s/Bachelor’s degree preferred.
- 1 year of document control/archival experience required; experience in a laboratory, pharmaceutical, or clinical research setting preferred.
- Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA strongly preferred.
- Archiving. Establish and maintain archiving process to support ACM Global Laboratories’ Rochester, NY site. Laise with commercial archive partners (Iron Mountain)
- Process Improvement. Develop and ensure Standard Operating Procedures (SOPs) for archival process; review processes and standardize globally when appropriate.
- Audit Support. Assist in audit preparation in advance of customer/regulatory site visits. Support the document scanning team to ensure appropriate digital archiving.