Quality Assurance Specialist

Job Description

Job 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.

Duties and Responsibilities:

• 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.
• Bachelor’s degree required (Science preferred, Business and other disciplines considered).
• Experience with electronic QMS applications including Veeva Vault Quality, Track Wise, ServiceNow, First Docs, 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.