Senior Calibration & QA Specialist – cGMP

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

Benefits offered by this job

Health and Wellness programs

Retirement plan

Job summary

Leidos Biomedical Research, Inc. at the Frederick National Laboratory seeks a Calibration Specialist to support initial compliance and ongoing QA processes for cGMP manufacturing in a vaccine program.

The role focuses on calibration, testing, documentation, and cross-functional collaboration within a regulatory framework. Ideal candidates have 5+ years in calibration, strong QA knowledge, and the ability to obtain a security clearance while working on-site in Frederick, MD.

Qualifications

• Bachelor’s degree from an accredited college/university in a related field; 4 years substitutable experience allowed.
• Minimum of five (5) years of progressively responsible calibration experience.
• Must possess basic Microsoft Office skills.
• Must understand quality systems compliant with FDA regulations for cGMP.
• Experience calibrating controlled temperature units and utility systems.
• Ability to obtain and maintain a security clearance.

Responsibilities

• Assist and support initial compliance and ongoing preparation, testing and monitoring of conformance to QA standards.
• Evaluate internal controls, risk assessments and documentation per safety, quality and regulatory standards.
• Identify risk and remediate deficiencies with internal departments.
• Facilitate internal training on QA requirements and procedures.
• Perform or participate in cross-functional risk assessments.
• Calibrate equipment and instruments to meet specifications and maintain calibration records.
• Create and revise SOPs and generate work orders and calibration reports.
• Maintain RAM database and coordinate on-site/off-site calibration activities.

Skills

Calibration

Quality Assurance

Documentation

Education

Bachelor’s degree in related field

Job description

Leidos Biomedical Research, Inc. at the Frederick National Laboratory seeks a Calibration Specialist to support initial compliance and ongoing QA processes for cGMP manufacturing in a vaccine program.

The role focuses on calibration, testing, documentation, and cross-functional collaboration within a regulatory framework. Ideal candidates have 5+ years in calibration, strong QA knowledge, and the ability to obtain a security clearance while working on-site in Frederick, MD.