GxP Quality & Records Specialist

Planet Pharma; New Haven (CT); On-site; USD 41,000 - 52,000; Full time

Job summary

Planet Pharma in New Haven, CT seeks a GxP Document Control Specialist to ensure quality and compliance of active and archived GxP records while providing administrative support and QA expertise.

You will serve as on-site point-of-contact for GXP records, manage archival processes, verify controlled documents in Veeva Vault ECMS, and support audit requests with cross-functional teams.

Qualifications

• 4–6 years experience in document control or QA in a GxP-regulated environment.
• 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, etc.
• Ability to work independently under minimum supervision.

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 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.

Skills

Independent worker

GMP knowledge

Education

Bachelor's degree

Tools

Veeva Vault Quality

TrackWise

ServiceNow

FirstDocs

Microsoft Office

Job description

Planet Pharma in New Haven, CT seeks a GxP Document Control Specialist to ensure quality and compliance of active and archived GxP records while providing administrative support and QA expertise.

You will serve as on-site point-of-contact for GXP records, manage archival processes, verify controlled documents in Veeva Vault ECMS, and support audit requests with cross-functional teams.