Posted 9 months ago  

Quality Validation Specialist

Posted 9 months ago - 153 views - 20 Applied

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.