Quality Assurance Specialist

Quality Assurance Specialist III

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.

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 with in Document Control (processing, verification, and archiving);
  Quality Assurance, Quality Systems, or 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, Track Wise, Service Now, First Docs, Client 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.