Sr. Computer Validation Specialist

Job Description Summary

The Sr. Computer Validation Specialist will be the leader for our IT QA team and responsible to create IT quality framework within OmniSeq. The role will work closely with software engineers, QA team, lab scientists and other departments to ensure OmniSeq deliver the highest quality software for patient care and comply to regulations from CAP, CLEP and FDA.

Job Responsibilities

  • Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
  • Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
  • Perform assessment of version/change control and new software rollouts.
  • Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
  • Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, MDSAP).
  • Represent the quality and compliance department in area(s)of expertise, as and when necessary.
  • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill client and PPD requirements.
  • May perform vendor and internal audits and/or regulatory inspections.
  • Perform Data Integrity risk assessment of laboratory systems.
  • Prioritize risks and work with IT, QA, and Laboratory personnel to address Data Integrity gaps.
  • Evaluate proposed and existing instrument systems and laboratory applications for Data Integrity gaps.
  • Keeps informed of all existing and new regulatory requirements and ensures full compliance in the Company’s Quality Systems.

Job Requirements

  • B.S. in computer or related field required.
  • Equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job.
  • Working knowledge of applicable GxP regulations, particularly 21 CFR Part 11, and current FDA/MHRA guidance on Data Integrity
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint)
  • Expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
  • Knowledge of all GxP regulations including international regulations
  • Knowledge of applicable parts of 21 CFR regulations
  • May require knowledge of ISO standards where applicable
  • experience working with Information Technology and a fundamental understanding of IT concepts
  • experience in a computer systems validation or quality assurance role