QC Instrumentation Specialist

Job Responsibilities

• Lead IQ/OQ/PQ activities and manage all CQV documentation, including SOPs, protocols, and reports.
• Oversee calibration, maintenance, and qualification of a variety of cGMP and non-cGMP instruments across Production, QC, and Facilities.
• Maintain equipment/service logs, schedule preventive maintenance, and manage vendor service contracts.
• Draft and review User Requirement Specifications (URS) and system suitability protocols.
• Troubleshoot instrumentation issues and supervise repair and verification processes.
• Ensure timely calibration and requalification to support on-time batch release.
• Maintain inventory of spare parts, backup instruments, and calibration tools.
• Serve as SME during audits and inspections; lead investigations related to equipment deviations and failures.
• Support alignment of SOPs with current regulatory standards (FDA, USP/EP, ICH, PDA, etc.).
• Recommend equipment or software upgrades and drive change controls as needed.

Qualifications

• Bachelor’s degree in a scientific or technical discipline, or equivalent experience.
• Hands-on experience with equipment qualification, calibration, and maintenance in a regulated (cGMP) environment.
• Strong understanding of analytical, production, safety, and environmental control instrumentation.
• Familiarity with industry guidelines and regulatory compliance requirements.
• Effective troubleshooting, documentation, and cross-functional collaboration skills.
• Experience leading or supporting audits, change controls, and equipment investigations.