QA Calibration Specialist III

About the Organization

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

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, 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 for global infectious diseases such as HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, and Tuberculosis. VCMP operates a pilot plant facility in Frederick, MD, engaged in cGMP manufacture, testing, release, and supply of Phase I/II clinical products for investigational use in the U.S. and globally.

Responsibilities

• Assist and support the organization with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
• Perform evaluation of internal controls, communications, risk assessments, and maintenance of documentation related to compliance with internal and external safety, quality, and regulatory standards.
• Identify risks and evaluate deficiencies, working with internal departments to appropriately remedy them.
• Facilitate internal training on quality assurance requirements, processes, and procedures.
• Participate in cross-functional teams performing risk assessments.
• Perform equipment and instrument calibration and testing to meet preapproved specifications, including adjustments as required.
• Create and maintain all calibration work in the Regulatory Asset Management (RAM) database used to track instrumentation status in cGMP manufacturing.
• Review executed instrument calibration records.
• Compile data and prepare Master Calibration Records and Instrument Calibration Records.
• Create and revise departmental Standard Operating Procedures (SOPs).
• Generate work orders and print calibration reports for daily and monthly activities.
• Perform daily updates of completed work in the RAM database.
• Schedule calibration vendors for on-site activities and manage off-site calibrations, including obtaining quotes and coordinating shipping.
• Train Calibration Specialist I/II on calibration principles and execution of complex equipment.

Requirements

• Bachelor’s degree from an accredited college or university in a related field (or 4 years of qualifying experience in Calibration, Validation, or Facilities/Engineering may substitute for education). Foreign degrees must be evaluated for U.S. equivalency.
• Minimum of five (5) years of progressively responsible calibration experience.
• Basic Microsoft Office skills.
• Understanding of quality systems compliant with FDA regulations for cGMP.
• Working knowledge of all aspects of calibration.
• Experience calibrating controlled temperature units (refrigerators, freezers, incubators) for temperature, humidity, and CO₂.
• Experience calibrating utility systems such as Water For Injection, Steam, and compressed gases for temperature and pressure.
• Experience calibrating equipment such as autoclaves, ovens, and isolators.
• Ability to clearly summarize and communicate calibration issues to equipment owners and staff.
• Experience maintaining databases and data entry.
• Experience writing/investigating Out of Tolerance conditions for equipment.
• Good writing skills.
• Ability to obtain gown certification and work aseptically in clean room conditions.
• Ability to obtain and maintain a security clearance.

Preferred Qualifications

• Experience in a cGMP environment.
• Basic knowledge of cGMP requirements related to maintaining calibrated instrumentation.
• Experience with Blue Mountain Regulatory Asset Management database.
• Experience working in an environment regulated by Standard Operating Procedures (SOPs).
• Ability to prepare timelines and project schedules using computer applications.
• Experience with Master Control or electronic Document Management Systems.

Physical Requirements

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

Job Hazards

This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.

Pay

76,800.00 - 110,103.00 USD. The posted pay range is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include responsibilities of the job, education, experience, knowledge, skills, abilities, internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part-time positions.

Benefits

Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave, and Retirement.