Senior QA Calibration Specialist (cGMP)

BioSpace; Frederick (MD); On-site; USD 77,000 - 110,000; Full time

Job summary

Leidos Biomedical Research, Inc. is seeking a Calibration Specialist to support the Vaccine Clinical Materials Program in the Frederick National Lab. The role focuses on calibration, validation, and QA processes within a cGMP framework, ensuring instrument accuracy and regulatory compliance.

The position requires deep calibration expertise, documentation discipline, and ability to work in a team environment to support manufacturing activities and regulatory readiness at the Frederick site.

Qualifications

• Bachelor’s degree in a related field; 4 years calibration/validation experience may substitute.
• 5 years of progressively responsible calibration experience.
• Working knowledge of FDA quality systems compliant with cGMP.
• Ability to obtain gown certification and work aseptically in clean room conditions.
• Experience calibrating instruments and utility systems (refrigeration, WFI, steam, gases).

Responsibilities

• Assist with initial compliance and ongoing QA for manufacturing calibration.
• Evaluate controls, risk assessments and maintain documentation.
• Identify deficiencies and work with internal teams to remediate.
• Facilitate internal training on calibration requirements, processes and procedures.
• Create and maintain calibration data in RAM and related records.
• Schedule calibration vendors and manage off-site calibrations.
• Create Master Calibration Records and Instrument Calibration Records.
• Draft and revise SOPs and generate work orders.

Skills

Microsoft Office

Communication skills

Teamwork

Calibration knowledge

FDA cGMP awareness

Education

Bachelor's degree in related field

Tools

Blue Mountain RAM

MasterControl

Electronic Document Management Systems

Job description

Leidos Biomedical Research, Inc. is seeking a Calibration Specialist to support the Vaccine Clinical Materials Program in the Frederick National Lab. The role focuses on calibration, validation, and QA processes within a cGMP framework, ensuring instrument accuracy and regulatory compliance.

The position requires deep calibration expertise, documentation discipline, and ability to work in a team environment to support manufacturing activities and regulatory readiness at the Frederick site.