Posted 1 year ago  

Quality Validation Specialist

Job Description

Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.

Job Description

  • Review and approve UAT test scripts to ensure accuracy and completeness
  • Review and approve completed UAT test scripts to ensure they are complete and contain objective evidence, as required
  • Review and approve validation documentation to ensure it is accurate and complete
  • Ensure documentation adheres to the processes and meets required standards
  • Review and approve documentation and reports, associated with the validation of products
  • Works closely with other departments and functions to promote processes that ensure consistency, continuous improvement, and compliance with quality and business requirements across activities
  • Provide QA oversight for GxP validation activities and apply a risk-based methodology to validation efforts
  • Provide QA assessment and review of GxP validated systems-related procedures, deviations, CAPAs, and change controls
  • Provides guidance/mentoring to junior members of the QA team on less complex issues
  • Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to GxP
  • Identify, record, document, and track non-conformity issues
  • Manage nonconformity issues and support the development and implementation of solutions
  • Review and approve change requests
  • Other duties as assigned

Qualifications

  • 4+ years working in Software Development or a combination of education and experience
  • Bachelor’s degree in Computer Science, Engineering, or related field
  • Experience working in a GxP environment
  • Experience performing validation work to meet 21 CFR Part 11, 21 CFR Part 820, ICH GCP, ISO 13485, and ISO 14971 requirements
  • Experience as a Quality Assurance Engineer (preferred)
  • Experience writing test scripts
  • Experience testing mobile apps, web apps, and APIs
  • Experience developing software (preferred)
  • Critical thinking and problem-solving skills
  • Great interpersonal and communication skills
  • Attention to detail
  • Flexibility and adaptability on managing/prioritizing multiple tasks

Desired Software Skills:

  • Postman, Charles Proxy, Jira, Jmeter, H20, Oracle DB, SQL server, Kobiton, Confluence, Gitlab, Github

Additional Information

All your information will be kept confidential according to EEO guidelines.

Job Stats

Posted 1 year ago - 190 views - 23 Applied