The Mid-Level Instrumentation QA/QC Inspector is responsible for inspecting, verifying, and documenting the compliance of instrumentation and control systems in laboratory environments with regulatory and internal standards (e.g., GMP, GLP, ISO). This role plays a critical part in ensuring that laboratory instrumentation is installed, calibrated, and qualified according to validated protocols and engineering specifications.
Instrumentation Inspection and Compliance Verification
Conduct inspections of field-installed instruments (e.g., pH, conductivity, pressure, temperature, flow sensors) in lab settings.
Verify installation and calibration against P&IDs, hook-up drawings, and project specifications.
Ensure compliance with GMP/GLP, ISO 17025, and FDA 21 CFR Part 11 standards.
Calibration and Testing Oversight
Witness calibration and loop testing activities.
Review and approve calibration certificates, traceability records, and IQ/OQ documentation.
Ensure instruments meet accuracy and repeatability standards required for regulated lab processes.
QA/QC Documentation Management
Maintain comprehensive QA records, inspection checklists, non-conformance reports (NCRs), and change control documentation.
Prepare QA/QC portions of turnover packages and support system readiness for validation and audits.
Compliance Audits and Quality Assurance
Participate in internal audits and prepare pre-audit assessments.
Support CAPA processes and ensure timely resolution of instrumentation-related deviations or quality issues.
Cross-Disciplinary Collaboration
Work closely with commissioning, automation, validation, and lab operations teams to ensure integrated QA/QC compliance.
Provide technical feedback during design reviews and FAT/SAT activities related to instrumentation.
Standards and SOP Enforcement
Monitor adherence to SOPs and lab-specific QA protocols for instrument installation, calibration, and maintenance.
Identify gaps in implementation and recommend improvements to QA processes.
Training and Mentorship
Mentor junior QA/QC inspectors or interns on compliance documentation, inspection techniques, and GMP practices.
Assist in developing QA checklists and field guides for lab instrumentation compliance.
Education:
Diploma or Degree in Instrumentation, Electronics, or Electrical Engineering.
Experience:
3–5 years of experience in instrumentation QA/QC roles, preferably in a regulated laboratory, biotech, or pharmaceutical environment.
Technical Skills:
Strong understanding of laboratory-grade instrumentation and control systems.
Proficiency in reviewing calibration standards, P&IDs, and hook-up drawings.
Familiarity with quality systems such as ISO 9001, ISO 17025, GMP, GLP.