Zortech Solutions

QA Testing

Zortech Solutions Santa Monica, CA
Zortech Solutions

QA Testing

Zortech Solutions Santa Monica, CA
3 months ago
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Role: QA Testing

Location: Santa Monica (working 3 days a week from office)

Duration: 6-12 Months

Job Description

  • Participate in meetings (status updates, aligning with stakeholders, resolving questions from cross functional teams)
  • Change control CSV impact assessments (meeting with stakeholders for COI/COC systems)
  • Review change control records
  • EBS change control records
  • Kite change control records (pre-approval and action items, completed action items, CC closure)
  • Draft plans (Val plan or Computer System Change Assessment) and draft VSR
  • Reviews (SDLC documents, post-executions, EC's)
  • UAT sit-in sessions to ensure requirements are being followed if UAT is being leveraged for PQ, defect reviews/approvals
  • Kite Konnect hotfixes/emergency fixes (review TIA, review evidence)

Qualifications

  • Experience in startup or fast paced company, nice to have experience in cell therapy company
  • Extremely detail-oriented
  • Good in taking direction
  • Effective communicator
  • Good education
  • Easy to work with personality
  • Have at least 5 years experience leading CSV projects from beginning to end, creating all SDLC documents, data migrations, system decommissioning
  • Familiar with regulations 21 CFR Part 11, EU Annex 11, data integrity principles, GDP

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Other

  • Industries

    IT Services and IT Consulting

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