GxP Document Control & Archive Specialist

Integrated Resources, Inc ( IRI ); Harvard (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Integrated Resources, Inc (IRI) seeks a records and quality control professional to ensure GxP documentation compliance and robust archival processes at the New Haven site. The role provides cross-functional support, process expertise, and QA oversight in a fast-paced biopharma-like environment.

Responsibilities include managing GXP archives, validating documents in Veeva Vault ECMS, and collaborating with owners on ECMS queries while maintaining high data integrity and regulatory alignment.

Qualifications

• 4-6 years’ experience in Document Control or QA in a GxP-regulated setting.
• Bachelor’s degree required (Science preferred).
• Experience with electronic QMS apps such as Veeva Vault Quality, TrackWise, ServiceNow, FirstDocs, MS Office.

Responsibilities

• Primary point of contact for on-site GXP records archiving at the New Haven, CT site.
• Manage GXP archives including logging requests, retrieving records, and coordinating with vendor for archiving.
• Oversee enterprise archiving & retention processes under manager guidance.
• Collaborate with Analytical Sciences lab for Lab Notebook/Logbook processes.
• Verify controlled documents in Veeva Vault ECMS for compliance.

Skills

Document control

Quality Assurance

GxP compliance

Data Integrity

Education

Bachelor's degree

Tools

Veeva Vault Quality

TrackWise

ServiceNow

FirstDocs

Microsoft Office

Job description

Integrated Resources, Inc (IRI) seeks a records and quality control professional to ensure GxP documentation compliance and robust archival processes at the New Haven site. The role provides cross-functional support, process expertise, and QA oversight in a fast-paced biopharma-like environment.

Responsibilities include managing GXP archives, validating documents in Veeva Vault ECMS, and collaborating with owners on ECMS queries while maintaining high data integrity and regulatory alignment.