Senior Calibration Specialist – cGMP Quality & Compliance

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

Job summary

Leidos Biomedical Research, operating Frederick National Laboratory, seeks a skilled Calibration Specialist to support QA conformance and cGMP manufacturing calibration. You will calibrate instruments, maintain calibration records, and help ensure compliance across facilities.

Strong writing and procedural skills are essential. The role requires 5+ years in calibration, experience with temperature control units, and ability to work aseptically in a clean room; gown certification may be required.

Qualifications

• Bachelor’s degree from an accredited college in a related field (CHEA); 4 years calibration/validation experience may substitute.
• Minimum of five years of progressively responsible calibration experience.
• Must possess basic Microsoft Office skills.
• Must understand quality systems compliant with FDA regulations for cGMP.
• Must have experience calibrating temperature control units and utility systems.
• Must be able to obtain gown certification and work aseptically in clean room conditions.

Responsibilities

• Assist and support QA with conformance to established QA processes and standards for manufacturing.
• Evaluate internal controls, risk assessments and maintain documentation.
• Identify risk and deficiencies and coordinate with internal teams to remediate.
• Train internal staff on QA requirements and procedures.
• Calibrate equipment and instruments; maintain calibration records and RAM database.
• Create and revise SOPs and generate work orders.

Skills

Calibration

Quality systems

FDA cGMP

Microsoft Office

Data entry

Documentation

Education

Bachelor's degree in related field

Tools

Blue Mountain RAM

Job description

Leidos Biomedical Research, operating Frederick National Laboratory, seeks a skilled Calibration Specialist to support QA conformance and cGMP manufacturing calibration. You will calibrate instruments, maintain calibration records, and help ensure compliance across facilities.

Strong writing and procedural skills are essential. The role requires 5+ years in calibration, experience with temperature control units, and ability to work aseptically in a clean room; gown certification may be required.