Summary

cGMP Consulting, Inc. is seeking an individual to coordinate all aspects of calibrations which include training of instrument users to provide on-time calibration for instrumentation and improve performance through improved calibration system. Additionally, be the liaison with instrument owners, department management, instrument calibration technicians, and corporate metrology administration personnel to improve performance through the calibration system. This person will control instrument calibration dates (due dates and status reports) by interfacing with users and calibration agencies and support instrument compliance issues.

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, and address high priority requests. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.

Responsibilities

• Review and approve calibration request for correctness (process/product specifications) are met; that all data required are documented per Basic and Standard Operating Procedures and Policies.
• Coordinate nonconformance issues (CAPA and Audit).
• Support CAPA requirements, initiate/submit Calibration Alerts.
• Advise instrument owners/departments on calibration related issues.
• Assure that adequate programs exist at the user level to ensure that users are properly trained in the use and care of the calibrated instruments used.
• Follow up and resolution of CAPA NCRs issues for calibration alerts.
• Coordinate all calibration audit activities, including representation during audits, CAPA plans, and observation closure.
• Follow up and analysis for calibration metrics.
• Project work related to calibrations and/or instrumentation issues.
• Managing and setting up of data in temperature and process monitoring system per requirements for excursions and escalations.

Requirements

• Minimum 4-year degree in technical field or sciences.
• 3-5 years of relevant experience in calibration and instrumentation in production.
• Use of various software packages in the development of calibration metrics. Use of Calibration Systems: Maximo, SAP, Vaisala, and Manufacturing Enterprise System.
• Strong project management skills, organizational skills, and computer knowledge.