Quality Assurance Specialist

About the role

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.

Hybrid schedule: onsite 3 days/week in New Haven, CT. Initial duration: 12 months.

Responsibilities

• Serve as the primary point-of-contact for on-site GxP records archiving at the New Haven, CT site.
• Manage 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.
• Manage the Enterprise Archiving & Retention business process and associated processes with direction from the Manager, Documentation Services.
• Manage Lab Notebook/Logbook processes in collaboration with the Analytical Sciences lab onsite.
• Perform verification of controlled documents within the Veeva Vault Quality Enterprise Content Management System (ECMS) for compliance to procedures.
• Provide excellent customer service support for service requests related to ECMS, document management processes, audit and inspection requests, and collaborate with document owners/authors for any ECMS documentation-related queries.
• Serve as a subject-matter expert (SME) for Document Management, ECMS, Good Documentation Practices/ALCOA+, Data Integrity/Data Compliance, and other areas as assigned.

Requirements

• 4–6 years of experience within Document Control (processing, verification, and archiving), Quality Assurance, Quality Systems, or a related role in a GxP-regulated biopharma, medical device, or similar industry.
• Bachelor’s degree required (science preferred; business and other disciplines considered).
• Experience with electronic QMS applications including Veeva Vault Quality, TrackWise, ServiceNow, FirstDocs, and Microsoft Office Applications.
• Ability to work independently under minimum supervision.
• Experience in developing, implementing, and evaluating archives or records management processes and systems, including cataloging, filing, 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.