Position Summary
This role is responsible for ensuring quality and compliance of active GxP documentation and archived GxP records, as well as providing administrative support, technical and process-expertise, quality assurance, and general consulting as needed.
Principal Responsibilities Areas of responsibilities include, but are not limited to :
- Serving as the primary Point-Of-Contact for on-site GXP records archiving at the New Haven, CT site.
- Managing GXP Archives at the New Haven, CT site including receiving and logging archive requests, retrieving Records from internal customers, and coordinating with Records vendor / supplier to retrieve and archive records.
- Managing the Enterprise Archiving & Retention business-process and associated processes with direction from the Manager, Documentation Services.
- Managing Lab Notebook / Logbook processes in collaboration with the Analytical Sciences lab onsite.
- Performing verification of controlled documents within the Veeva Vault Quality Enterprise Content Management System (ECMS) for compliance to procedures.
- Providing excellent customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests, and collaborating with document owners / authors for any ECMS documentation related queries.
- Serving as a subject-matter-expert (SME) for Document Management, ECMS, Good Documentation Practices / ALCOA+, Data Integrity / Data Compliance, and other areas as assigned.
Qualifications
- 4 - 6 Years Experience within Document Control (processing, verification, and archiving); Quality Assurance, Quality Systems, or related role in a GxP-regulated biopharma, medical device, or similar industry.
- Bachelors degree required (Science preferred, Business and other disciplines considered).
- Experience with electronic QMS applications including Veeva Vault Quality, TrackWise, ServiceNow, FirstDocs, Microsoft Office Applications, etc.
- Ability to work independently under minimum supervision.
- Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving records, and creation and management of record retention schedules.
- Experience with GMP global regulatory requirements.
- Knowledge of archival metadata and metadata management.
- Ability to work in a fast-paced environment.
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