Job Details - QA Calibration Specialist - 49435828 | Frederick National Laboratory Talent Network
Join our Talent Network

QA Calibration Specialist in Frederick, MD

Location: Frederick, MD
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech



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 to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of 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 US and globally.


  • Perform equipment and instrument calibration and testing to meet preapproved specifications and perform adjustments as required.
  • Create and maintain all calibration work in the RAM database used to track the status of instrumentation used in cGMP manufacturing.
  • Cross-train with validation engineers to perform equipment validations, operation and performance qualification protocols.
  • Review executed instrument calibration and validation documentation.
  • Compile data and prepare final reports.
  • 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.


To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years of relevant experience in Calibration, Validation or Facilities/Engineering in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
  • No experience required with a Bachelors 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 staff.
  • Experience in maintaining databases and data entry.
  • Ability to obtain and maintain a security clearance


  • Ability to 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 50lb, 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 small amounts of time.
  • Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
  • Pacemaker prohibited.


Candidates with these desired skills will be given preferential consideration:

  • Experience in a cGMP environment.
  • Basic knowledge of cGMP requirements as it relates to maintaining calibrated instrumentation.
  • Experience with Blue Mountain Regulatory Asset Management database.
  • Experience working in an environment regulated by Standard Operating Procedures (SOPs).

 Apply on company website
Powered by CareerArc