QA Calibration Specialist III

Location
Frederick, MD, USA
Posted
Nov 22, 2018
Ref
JR116-70098
Hotbed
BioCapital
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.

KEY ROLES/RESPONSIBILITIES
  • 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

BASIC QUALIFICATIONS
  • 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

PREFERRED QUALIFICATIONS
  • 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)