QA Calibration Specialist

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Laboratory, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical‑stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV‑AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis).

The VCMP operates a Frederick‑MD‑based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I/II clinical products for investigational use in the U.S. and globally.

• Perform equipment and instrument calibration and testing to meet pre‑approved specifications and conduct adjustments as required.
• Create and maintain all calibration work in the RAM database used to track the status of instrumentation used in cGMP manufacturing.
• Review executed instrument calibration.
• Compile data and prepare Master Calibration Records and Instrument Calibration Records.
• Create and revise departmental Standard Operating Procedures (SOPs).
• Generate work orders.
• Print out calibration reports for daily and monthly activities.
• Perform daily updates of completed work in the RAM database.
• Schedule calibration vendors for on‑site activities.
• Manage off‑site calibrations, including working with vendors to obtain quotes and appropriate shipping information.

• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Qualifying experience (4 years) in calibration may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• No experience required with a Bachelor’s degree.
• Must possess basic Microsoft Office skills.
• Must understand quality systems compliant with FDA regulations for cGMP.
• Must have good writing skills.
• Must have the ability to clearly summarize and communicate calibration issues to equipment owners and staff.
• Experience in maintaining databases and data entry.
• Must be able to obtain gown certification and work aseptically in clean‑room conditions.
• This position is considered safety sensitive and will be subject to random drug testing per the Leidos Biomedical Research Drug‑Free Workplace Program.
• Ability to obtain and maintain a security clearance.

• Maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use both hands, arms, and legs (prosthetic allowed), use all fingers, carry up to 50 lb, reach above shoulders, climb ladders, push/pull, repeated bending, and stand for extended periods.
• Respond to verbal instruction and cues in a sterile environment where staff are wearing face masks.
• Wear Personal Protective Equipment (PPE).
• Enter a laboratory or encounter a hazardous area.
• Operate and/or service equipment that contacts or transports compressed or liquid gas.
• Withstand exposure to temperatures below 32 °F indoors for short periods.
• Visual acuity with depth perception, color distinction, and vision correctable to 20/40.
• Pacemaker prohibited.

• Experience in a cGMP environment.
• Basic knowledge of cGMP requirements as they relate to maintaining calibrated instrumentation.
• Experience with Blue Mountain Regulatory Asset Management database.
• Experience working in an environment regulated by Standard Operating Procedures (SOPs).
• Experience calibrating controlled‑temperature units (e.g., refrigerators, freezers, incubators for temperature, humidity, and CO₂).
• Experience calibrating facility utilities (e.g., WFI, compressed gases).
• Experience calibrating autoclaves and ovens.
• Experie…