GxP Documentation & Archiving Specialist (Hybrid)

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

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.