Senior Metrology Technician – GMP/GxP Calibration Expert

ALOIS Solutions; Morrisville (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

ALOIS Solutions is seeking a Calibration Technician to manage the calibration, maintenance, and repair of laboratory equipment in a GMP-regulated environment in Morrisville, NC. The role focuses on quality review of documentation and initiating deviation investigations related to metrology.

Responsibilities include performing calibration on active equipment, reviewing vendor work, ensuring FDA/GxP compliance, and maintaining calibration documentation within the CMMS.

Qualifications

• 10+ years of metrology experience with Pharma/Biotech preferred or 6+ years with a Bachelor’s Degree.
• Experience investigating CAPAs and deviations in a GxP environment.
• Strong understanding of calibration methodology, tolerances, and FDA regulations.

Responsibilities

• Manage calibration, maintenance, and repair of laboratory equipment in compliance with GxP regulations.
• Review and approve calibration and maintenance documentation performed by external vendors.
• Initiate and assist with investigations related to instrument calibration failures or issues (Deviations/CAPAs).
• Oversee onsite vendors to ensure training and compliance for calibration activities.
• Develop calibration requirements and schedules for new equipment with owners and schedulers.
• Maintain SOPs and controlled documents for the calibration program and ensure data integrity in the CMMS.

Skills

Metrology experience

CAPA investigations

GxP regulatory knowledge

Calibration methodology

Education

Bachelor’s Degree in Metrology or related field

High School Diploma

Tools

CMMS

Job description

ALOIS Solutions is seeking a Calibration Technician to manage the calibration, maintenance, and repair of laboratory equipment in a GMP-regulated environment in Morrisville, NC. The role focuses on quality review of documentation and initiating deviation investigations related to metrology.

Responsibilities include performing calibration on active equipment, reviewing vendor work, ensuring FDA/GxP compliance, and maintaining calibration documentation within the CMMS.