Calibration Associate II

Overview

Make the move to biotech and join a seasoned, high functioning team. Oversee daily activities of a GMP, GLP, and research calibration program. Schedule calibration services, coordinate vendors, oversee onsite calibrations, review completed certifications, and process Out-of-Tolerance reports.  Assist with other GxP program and validation support and documentation. 

Responsibilities

• Develop and maintain a high level GMP/GLP/research calibration program.
• Direct activities for equipment calibrations and process Out-of-Tolerance reports on a variety of instrumentation, manufacturing, and analytical equipment.
• Review and provide specifications and guidance for new instrumentation purchases.
• Perform continuous monitoring of instrument status, condition, and location.
• Assist with integration of calibration and preventative maintenance activities into a uniform scheduling program.
• Provide documentation support to instrument owners and other departments in support of their activities or informational needs.
• Provide Vaisala equipment monitoring for devices that may be starting to fail or are showing signs of drift.
• Assist with the transition from a paper-based to a cloud-based calibration tracking system.     

Qualifications

• Experience in a GMP/GLP or other regulated facility.
• Strong communication and organizational skills.
• Experience with calibration program or other facility related program administration.
• Experience with Microsoft products.
• Strong computer skills and experience with Vaisala viewLinc and/or Blue Mountain a plus.
• 0–3 years’ experience in a GMP/GLP environment or other regulated facility.
• Associate or Bachelor’s degree preferred.
• 2 years’ documentation experience in a regulated industry.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.