Quality Assurance Specialist|ALX|US

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. We work, on average, a minimum of three days per week from the office, balancing in-person collaboration with individual flexibility.

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.

Pay

$30–38.66/hour depending on experience.