Software Quality Assurance Computer Systems Validation Specialist - Remote
Development & Test
Newark Direct Hire Aug 18, 2023
100% REMOTE -  Software Quality Assurance Computer System Validation Specialist opportunity! CSV!
Our client a Global materials science company is looking for a Software Quality Assurance Computer System Validation Specialist. . In this role, you will be responsible for ensuring the fitness-for-use of the computer systems. The Software Quality Assurance Computer System Validation Specialist will be responsible for working with functions throughout the organization to successfully carry out the computer system validation strategy through a risk-based approach that ensures the quality and integrity of data over the entire system lifecycle. This is a remote position, and you can work from home in most locations within the United States.

  • Ensure that the quality system elements necessary to achieve and maintain compliance across multiple businesses and varied regulatory requirements, are established and activities related to computer systems/software testing are controlled via these elements
  • Author, review and/or approve validation plans, protocols, and reports.
  • Ensure that test cases are documented and executed following the requirements set forth by procedures and external requirements
  • Work with appropriate teams to establish quality expectations related to software quality assurance and computer system validation
  • Collaborate with stakeholders in the preparation of software and hardware specification documents and test plans
  • Author, review and/or approve system change, configuration management, and supporting documentation activities
  • Participate in external/internal computer system/software audits
  • Support defect resolution
  • Support and monitor the qualification of Information Technology Infrastructure Platforms

  • Minimum 5 years of experience in a computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry
  • Demonstrated experience in software quality assurance processes, SDLC methodology, supplier quality management, change management, documentation, verification, periodic review, and validation techniques
  • Experience with ALM software
  • Understanding of current software quality-assurance techniques and software industry standards and their impact on internal procedures, and software quality
  • Demonstrated ability to author validation protocols and manage deviations
  • Excellent written and oral communication skills
  • Highly motivated
  • Demonstrated ability to work in a dynamic team environment
  • Ability to handle multiple projects and priorities with competing resources
  • Ability to communicate clear direction, commitments, and alignment

Desired Qualifications:
  • Bachelor’s degree in an applicable science
  • Experience with ERP, Product Lifecycle Management Systems, and/or Manufacturing Execution Systems