Quality Systems Contractor

Highly Competitive
  1. Contract
  2. Good Distribution Practice (GDP)
  3. United States
Cambridge, USA
Posting date: 29 Aug 2024
62051

Quality Systems Coordinator - Contract - Cambridge MA

Proclinical is seeking an experienced Quality Systems Contractor to join a dedicated team.

Primary Responsibilities:

The successful candidate will be required to support the implementation of process improvements and workflow optimizations within Document Control and Quality Systems. This role focuses on enhancing system integrations and ensuring compliance with regulatory standards.

Skills & Requirements:

  • Bachelor's Degree (BA/BS) preferred.
  • Experience in an FDA-regulated environment or similar.
  • Prior system administration experience, with a preference for Veeva Quality Suite.
  • Strong understanding of GxP Regulatory Requirements around Document Control and Training.
  • Knowledge of GxP Regulatory Requirements around Quality Management Systems.
  • Ability to work independently with attention to detail.
  • Strong interpersonal and organizational skills.
  • Proficiency in MS Word, Excel, and PowerPoint.
  • Project management skills.

The Quality Systems Coordinator's responsibilities will be:

  • Update Veeva meta-data, review existing configurations, and make necessary changes for system integrations.
  • Provide document processing support, including reviewing controlled GxP documentation for compliance with GDocP standards and internal processes.
  • Offer customer support for Veeva Quality Systems issues.
  • Support various process improvement initiatives as needed.
  • Manage Global Quality Systems SOP revisions.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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