Quality Assurance Specialist

eTeam; New Haven (CT); Hybrid; USD 70,000 - 100,000; Full time

Job summary

eTeam is hiring for a GxP Records Compliance & Documentation Specialist in New Haven, CT. This hybrid 12-month contract role covers GXP document control, archival management, and ECMS-related support.

You will act as SME for documentation practices, data integrity, and regulatory alignment, coordinating with vendors and internal stakeholders to ensure precise recordkeeping and readiness for audits.

Qualifications

• 4–6 years of document control/QA in a GxP-regulated environment.
• Bachelor’s degree required (Science preferred).
• Experience with electronic QMS apps (Veeva Vault, TrackWise, ServiceNow, FirstDocs, MS Office).
• Ability to work independently with minimal supervision.
• Experience creating and managing archives/records retention schedules.
• Knowledge of GMP global regulatory requirements.
• Knowledge of archival metadata management.
• Ability to thrive in a fast-paced environment.

Responsibilities

• Serve as primary point-of-contact for on-site GXP records archiving in New Haven, CT.
• Manage GXP archives at site: receive/log requests, retrieve records, coordinate with vendor.
• Oversee Enterprise Archiving & Retention processes under Documentation Services direction.
• Coordinate Lab Notebook/Logbook processes with onsite Analytical Sciences lab.
• Verify controlled documents in Veeva Vault ECMS for compliance.
• Provide excellent customer service for ECMS, document management, audits/inspections requests.

Skills

Document control

Quality assurance

GxP knowledge

Veeva Vault

ECMS

Data integrity

Customer service

Education

Bachelor’s degree (Science preferred)

Tools

Veeva Vault Quality

TrackWise

ServiceNow

FirstDocs

MS Office

Job description

Location: New Haven, CT (Hybrid - 3days onsite 2 remote)

Duration: 12 Months

Interview: 1 round of interview

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.

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.
• Bachelor’s 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.