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Integration QA Specialit

Alpha Consulting

This is a Contract position in Bothell, WA posted December 31, 2020.


Project Description:
This role is part of the site’s Quality Systems team and will be responsible for supporting department activities and Quality Management Systems processes to ensure GxP compliance. This hands-on individual partners with Quality Systems team members and site functions to develop and support process integration, implementation, and improvement to meet business and regulatory needs.

  • Support the site with application integrations (e.g. QualityDocs, Veeva Vault QMS, etc.) through maintenance, Quality administration, training, and process improvement implementations.
  • Collaborate and contribute to the writing, coordination, review, and maintenance of SOPs, training materials, job aids, and work instructions that drive effectiveness and efficiency into the business.
  • Conduct training of personnel on applicable integrated systems (e.g. Veeva Vault) and associated business processes.
  • Act as site QA lead in gathering requirements, supporting validation test verification, and administration of modules with the Quality Management System.
  • Establish and implement reporting tools within QMS for analysis, trending, and reporting system-related metrics.
  • Assist with User Acceptance Testing, as well as oversee and participate, as needed, in validation.
  • Collaborate closely with cross-functional teams across multiple locations to identify sound, scalable, and supportable integration solutions that meet or exceed business requirements across the organization.
  • Champion site feedback for lifecycles, workflows, security settings, objects, document types/subtypes, to the project team and / or organizational team meetings.
  • Draft and manage change management plans (i.e. communications, roll-out and training) for site implementation of integrated systems.
  • Act as site representative during internal and external audits and regulatory inspections related to the integration of systems / applications at the site.

Required Qualifications:

  • Experience implementing enterprise-scale solutions for Document or Quality Management Systems for life sciences as a consultant, business, or IT representative.
  • Direct experience with systems such as Veeva Vault, ETQ Reliance, Sparta TrackWise, SharePoint, and other quality information management or content management systems
  • Ability to effectively communicate complex technical information to personnel at all levels of the organization
  • Must be adaptable and able to operate effectively in a dynamic environment with often changing priorities.
  • Strong knowledge of cGMPs and regulatory requirements
  • Strong project planning skills.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, packaging, and labeling, etc.)
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio, and Excel) and with Quality Systems (e.g. Veeva Document Management System, electronic Quality Management System)

Required Skills:
Education: Bachelor’s degree or equivalent
Experience A minimum of 5 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: