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AIQ (Analytical Instrument Qualification) SME

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Katalyst HealthCares & Life Sciences
📍 Skaneateles Falls, United States
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Location Skaneateles Falls
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Posted June 19, 2026
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Commute Local Area
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Local Opportunity Near You!

This job is in your area. Enjoy a short commute and work close to home.

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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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    📍 Location Details

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    City
    Skaneateles Falls
    🗺️
    Country
    United States
    🚗
    Commute
    Local Area

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