AIQ (Analytical Instrument Qualification)

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techdigital groupSkaneateles Falls (NY)

Quality Control Analysts Analytical Laboratory Instrument Manufacturing

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About the role

Key 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 5, FDA 21 CFR Part 11, and EU Annex 11 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 SME-level responses. Drive continuous improvement in qualification practices and documentation templates across global sites.

Qualifications: Bachelor's or Master's degree in Chemistry, Engineering, Life Sciences, or a related technical field. Experience in analytical equipment qualification, preferably in a GMP-regulated medical device or pharmaceutical environment. In-depth understanding of: FDA regulations (21 CFR Parts 820, 210/211, 11) GAMP 5 and ISO 13485 Data integrity principles (ALCOA+) Experience qualifying and maintaining Manufacturing equipment. Familiarity with electronic document systems, validation tools, and computerized system validation.

Preferred Qualifications: Certification in Lean Six Sigma, ASQ, or ISPE. Experience supporting global harmonization of validation practices across multi-site environments. Working knowledge of medical device testing requirements, especially for infusion devices, sensors, or diagnostic platforms.

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