JVT Advisors

GxP Quality Systems Engineer

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 6+ months

Job Summary: Reporting to the Associate Director, Quality Systems, the GxP Quality Systems Engineer will serve as a support of the technical design, development, delivery and maintenance of the GxP Compliance Systems - Quality Management, Document Management, Validation System Management. This position will play a key role in maintaining systems and the integrated processes to support the overall digital / IT QA compliance systems landscape.

 

Responsibilities:

  • System administrator support for the day-to-day administration of Veeva Quality Vault and Kneat Validation Management System.
  • Monitor help desk requests and incidents to troubleshoot critical production issues impacting end-users, including system lifecycles, workflows, security settings and object issues.
  • Work directly with the SaaS support teams to bring open service issues to a resolution by triage and monitoring progress.
  • Support issue resolution, continuous process improvements and routine system updates of Veeva Quality Vaults and other compliance systems.
  • Consult with the compliance business areas on development and managed deployment of system enhancements to ensure efficient usage and maintenance of technology.
  • Ensure current system functionality is maintained and assess impact and integrity of introducing new functionality into systems.
  • Support requirement definition and provide technical design insight within the applications and integrations between compliance systems other GxP systems (ERP, LIMS and MES) and Partner Systems.
  • Create and maintain GxP computer system deliverables including user requirements, system specifications and validation test scripts.

 

Requirements:

  • A bachelor’s degree in science, technology or another relevant academic discipline.
  • 5-8 years’ experience implementing and maintaining technology to support GxP QS processes.
  • Excellent interpersonal and communication skills with ability to work collaboratively within a team of stakeholders and influence decisions.
  • Must have a customer service mindset.
  • Quality orientated with strong attention toward details.
  • Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
  • Experience with Veeva Vaults (eTMF, Quality (Docs and eQMS). Experience with SAP SuccessFactors learning management, Please Review and Validation Management System (Kneat) is a plus.
  • Expertise with computer systems validation practices (GAMP).
  • API, data report development and systems integration.
  • Technical writing skills required.

 

Ovrille Gonsalves

Recruiting Lead

Ovrille is responsible for full lifecycle recruiting for JVT’s clients across several industry verticals. He supports the Contract Recruiting team, and specializes in identifying temp (contractual) and temp-to-perm resources for JVT’s clients.

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