Instrumentation QA/QC Inspector – Lab Standards Compliance

The Senior Instrumentation QA/QC Inspector leads the quality inspection, documentation review, and compliance verification of laboratory instrumentation and control systems. This role is critical for ensuring strict adherence to GMP/GLP, ISO 17025, and FDA 21 CFR Part 11 standards in laboratory and controlled environments. The inspector collaborates with engineering, calibration, and validation teams to maintain high-quality, audit-ready systems.

✅ Key Focus Areas:

1. Advanced Instrumentation Inspection & Quality Oversight

   • Lead QA inspections for installation, calibration, and commissioning of lab instrumentation such as analytical sensors, transmitters, and control devices.

   • Ensure traceability, material verification, and regulatory compliance of all instruments used in qualified lab zones.

2. Regulatory Compliance & Documentation Governance

   • Enforce compliance with GMP, GLP, ISO 17025, and FDA 21 CFR Part 11 across all instrumentation and control systems.

   • Review and approve IQ/OQ/PQ documentation, FAT/SAT reports, calibration protocols, and non-conformance records.

3. Quality Audits and Risk Assessment

   • Participate in or lead internal and external audits related to instrumentation QA.

   • Conduct risk assessments and root cause analyses for instrumentation-related deviations and CAPAs.

4. Calibration & Metrology Verification Leadership

   • Ensure all instruments meet traceable calibration requirements and are compliant with internal quality thresholds.

   • Supervise third-party calibration providers and internal metrology programs.

5. Team Supervision & Technical Mentorship

   • Provide mentorship and technical guidance to junior and mid-level QA/QC inspectors.

   • Support team development through training on inspection protocols and regulatory changes.

6. QA/QC System Optimization

   • Recommend and implement improvements to instrumentation QA processes, including digital documentation systems and inspection workflows.

   • Develop and maintain SOPs and checklists to standardize quality practices across projects.

7. Cross-functional Coordination

   • Act as the key QA liaison with engineering, construction, validation, and lab operations teams during project execution.

   • Review instrumentation design packages and participate in design qualification (DQ) and validation strategy discussions.

Qualifications:

• Education:

  • Bachelor's degree in Instrumentation Engineering, Electrical Engineering, or related technical field.

• Experience:

  • 7–10 years of experience in QA/QC for lab instrumentation or control systems in regulated environments (e.g., pharmaceuticals, biotech, clinical labs).

• Technical Expertise:

  • Deep understanding of analytical instrumentation, loop checking, calibration standards, and regulatory expectations.

  • Proficiency with QA tools, document control systems, and audit preparation.