Global Calibration Steward – GMP & Regulatory Compliance

Ascential Medical & Life Sciences; Ham Lake (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Ascential Medical & Life Sciences is seeking a Calibration Coordinator in Ham Lake, MN. The role administers and maintains the calibration program to ensure compliance with FDA regulations (21 CFR Parts 210/211 and 21 CFR Part 820) and international requirements.

You will support product quality, data integrity, and inspection readiness across multiple jurisdictions. The position involves ensuring instruments and systems are calibrated, documented, and controlled per GMP and quality system

Qualifications

• Calibration, metrology, or maintenance experience in regulated pharma/biotech/medical device environments.
• Direct experience supporting global regulatory frameworks and audits.
• Strong knowledge of cGMP and global GMP frameworks (FDA, EU, WHO).
• Strong knowledge of ISO/IEC 17025 and calibration principles.

Responsibilities

• Coordinate and manage the calibration program for manufacturing, laboratory, and facility equipment.
• Maintain calibration schedules aligned with regulatory requirements and risk-based methodologies.
• Track and report KPIs such as completion rates, overdue calibrations, and OOT trends.
• Lead or support investigations for calibration failures and OOT conditions.

Skills

Calibration, metrology, maintenance

Education

Bachelor’s degree in Engineering / Life Sciences / Metrology

High School Diploma or AA Degree

Tools

CMMS systems (MasterControl / ETQ / SAP PM)

Job description

Ascential Medical & Life Sciences is seeking a Calibration Coordinator in Ham Lake, MN. The role administers and maintains the calibration program to ensure compliance with FDA regulations (21 CFR Parts 210/211 and 21 CFR Part 820) and international requirements.

You will support product quality, data integrity, and inspection readiness across multiple jurisdictions. The position involves ensuring instruments and systems are calibrated, documented, and controlled per GMP and quality system