Senior QA Calibration Specialist, cGMP Manufacturing

Frederick National Laboratory for Cancer Research; Frederick (MD); On-site; USD 76,800 - 110,103; Full time

Job summary

Frederick National Laboratory for Cancer Research is seeking a Calibration Specialist I/II to support QA compliance, calibration activities, and cGMP manufacturing processes at the Frederick facility. The role requires hands-on calibration of medical and laboratory equipment and maintenance of calibration records.

Responsibilities include coordinating calibration activities, generating calibration reports, and ensuring adherence to quality systems and regulatory standards.

Qualifications

• Bachelor’s degree in a related field; 4 years calibration/validation experience may substitute for education.
• Minimum of five years calibration experience.
• Must possess basic Microsoft Office skills.
• Must understand quality systems compliant with FDA regulations for cGMP.
• Working knowledge of calibration concepts and procedures.
• Experience calibrating temperature units (refrigerators, freezers, incubators) and utility systems.
• Experience calibrating equipment such as autoclaves, ovens, and isolators.
• Excellent writing skills and ability to communicate calibration issues clearly.
• Ability to obtain gown certification and work aseptically in clean room conditions.

Responsibilities

• Assist and support initial compliance and ongoing preparation for QA processes in manufacturing.
• Evaluate internal controls, communications, risk assessments, and related documentation.
• Identify risk and deficiencies; coordinate remediation with internal departments.
• Facilitate internal training on QA requirements, processes, and procedures.
• May participate in cross-functional risk assessment teams.
• Calibrate equipment to meet preapproved specifications and document adjustments.

Skills

Good writing

Teamwork

Microsoft Office

Communication skills

Quality systems knowledge

Education

Bachelor’s degree in related field

Tools

Blue Mountain RAM database

Master Control

Electronic Document Management Systems

Job description

Frederick National Laboratory for Cancer Research is seeking a Calibration Specialist I/II to support QA compliance, calibration activities, and cGMP manufacturing processes at the Frederick facility. The role requires hands-on calibration of medical and laboratory equipment and maintenance of calibration records.

Responsibilities include coordinating calibration activities, generating calibration reports, and ensuring adherence to quality systems and regulatory standards.