Senior Calibration Technician (GxP Metrology Expert)

IntelliPro Group; Morrisville (NC); Vor Ort; USD 63.000 - 89.000; Vollzeit

Zusammenfassung

IntelliPro Group in Morrisville, NC seeks a Calibration Technician V to manage calibration, maintenance, and repair of laboratory equipment, ensuring GxP compliance and quality documentation. The role focuses on metrology investigations under supervision and uses established procedures to solve routine problems.

You will coordinate with vendors, develop calibration acceptance criteria for new equipment, maintain SOPs in CMMS, and collaborate with QA, CSV, Facilities, IT.

Qualifikationen

• 10+ years metrology experience with a pharma/biotech focus or a Bachelor's + 6+ years in metrology.
• Experience investigating and completing CAPAs and deviations in a GxP environment.
• Strong understanding of calibration methodology, tolerances, and FDA regulations.

Aufgaben

• Independently calibrates and maintains active equipment including loop calibrations.
• Reviews calibration and maintenance documentation from external vendors.
• Ensures calibration activities comply with USP, NIST, FDA, GLP, GMP.
• Adheres to SOPs and QA guidance; maintains training in QMS.
• Initiates investigations for calibration failures (Deviations/CAPAs).
• Oversees onsite metrology vendors and approves external documentation.
• Inducts new equipment with calibration requirements and criteria.
• Documents activities and ensures data quality in CMMS.
• Collaborates with QA, CSV, Facilities and IT.

Kenntnisse

Metrology experience

CAPA investigations

FDA regulations

Calibration methodology

Ausbildung

Bachelor's Degree

High School Diploma

Jobbeschreibung

IntelliPro Group in Morrisville, NC seeks a Calibration Technician V to manage calibration, maintenance, and repair of laboratory equipment, ensuring GxP compliance and quality documentation. The role focuses on metrology investigations under supervision and uses established procedures to solve routine problems.

You will coordinate with vendors, develop calibration acceptance criteria for new equipment, maintain SOPs in CMMS, and collaborate with QA, CSV, Facilities, IT.