QC Instrumentation Specialist

About the role

The QC Instrumentation Specialist is responsible for the management, calibration, qualification, and maintenance of laboratory instrumentation at our Amman site. The role ensures compliance with cGMP, GLP, ICH guidelines and internal quality systems while supporting validation activities and continuous improvement.

Key responsibilities

• Coordinate and perform calibration, qualification, and preventive maintenance of laboratory instruments such as balances, pH meters, and Milli‑Q systems.
• Oversee corrective maintenance, manage spare parts, and maintain annual calibration schedules.
• Monitor environmental conditions (temperature, humidity) in freezers, refrigerators, stability chambers, and laboratory areas; conduct thermal mapping.
• Generate and execute validation documentation, including Validation Master Plans, protocols, URS, SOPs, and traceability matrices.
• Perform validation studies for laboratory instruments and computerized systems, ensuring periodic reviews meet validation requirements.
• Liaise with vendors and service providers for installation, calibration, and support; audit external providers for compliance.
• Maintain validation and calibration archives, master instrument history, and ensure data integrity (ALCOA++).
• Analyze quarterly out‑of‑calibration trends to drive continuous improvement.

Required profile

• Experience in calibration, qualification, and preventive maintenance of laboratory instrumentation.
• Strong knowledge of cGMP, GLP, ICH guidelines and data integrity standards.
• Ability to work onsite five days a week in Amman, Jordan.
• Experience with validation documentation and vendor management.

Required skills

• Calibration of balances, pH meters, Milli‑Q water systems.
• Preventive and corrective maintenance of freezers, refrigerators, stability chambers.
• Environmental monitoring and thermal mapping.
• Validation Master Plans, protocols, URS, SOPs, traceability matrices.
• Computerized system validation and periodic review.
• Vendor liaison and audit.
• Documentation archiving and data integrity (ALCOA++).
• Trend analysis of out‑of‑calibration events.