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AIQ (Analytical Instrument Qualification) SME

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Katalyst HealthCares & Life Sciences
πŸ“ Skaneateles Falls, United States
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Location Skaneateles Falls
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Posted June 19, 2026
πŸš—
Commute Local Area
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Job Description


Responsibilities:
  • Serve as the technical SME for qualification of analytical equipment in manufacturing setup.

  • Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP , FDA CFR Part , and EU Annex requirements.

  • Lead and support equipment lifecycle activities, including requalification, decommissioning, and periodic review.

  • Ensure data integrity compliance in computerized systems interfaced with analytical instruments.

  • Collaborate with Quality, Validation, Metrology, IT, and Lab teams to define qualification strategies for new and upgraded equipment.

  • Maintain traceability between user requirements, functional specifications, and qualification deliverables.

  • Provide guidance on change control and impact assessments for equipment modifications or upgrades.

  • Support audits and inspections by presenting qualification documentation and providing ...
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    πŸ“ Location Details

    πŸŒ†
    City
    Skaneateles Falls
    πŸ—ΊοΈ
    Country
    United States
    πŸš—
    Commute
    Local Area

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