QA Calibration Specialist III

Frederick, MD, USA
Nov 22, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

  • Perform equipment and instrument calibration and testing using NIST traceable standards to meet preapproved specifications and perform adjustments
  • Schedule calibration activities
  • Coordinate and implement preventive maintenance of standards
  • Train contractors on relevant SOPs
  • 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)
  • Perform data entry into RAM database
  • Perform follow up to ‘out of tolerance' events
  • Schedule calibration vendors for on-site activities
  • Manage off-site calibrations including working with vendors to obtain quotes and appropriate shipping information
  • Work may be required on 2nd or 3rd shift and weekends as needed to support manufacturing activities

  • Possession of a Bachelor's degree (qualifying experience may be substituted for the required education).
  • A minimum of five (5) years job related experience, or a minimum of three (3) years of experience in a cGMP environment
  • A minimum of 3 years performing Metrology/Calibration services in a cGMP environment
  • Must understand quality systems compliant with FDA regulations for cGMP
  • Must have good writing skills
  • Ability to clearly summarize and communicate calibration issues to staff and management
  • Experience in maintaining databases and data entry
  • Working knowledge of Microsoft Office
  • Must be able to obtain and maintain a clearance

  • 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 with Trackwise

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)