Priority One Services

Priority One Services

703-971-5505

Job Description

We are currently seeking a Quality Assurance Manager for our contract in Jefferson, AR at the Food and Drug Administration (FDA).
JOB SUMMARY The Quality Assurance Manager is responsible for developing, implementing and oversight of the Quality Assurance Program at the FDA animal research facility. This position will conduct inspections of a variety of processes to ensure compliance with applicable regulatory requirements, standards, corporate policies and procedures at the FDA animal research facility. RESPONSIBLITIES AND DUTIES :

  • Responsible for ensuring that the process followed for Good Laboratory Practice (GLP) studies are performed correctly and documented properly.
  • Monitor each regulated study to assure equipment, personnel and methods are in conformance with applicable regulations.
  • Maintain a master schedule of all non-clinical laboratory studies conducted by the testing facility that require animal care, technical procedures or formulation support, containing detailed information on studies.
  • Maintain copies of all protocols pertaining to regulated non-clinical laboratory studies, and inspect each study at intervals to assure its integrity.
  • Provide results of each inspection to the study director and contract management.
  • Ensure that there are no deviations from protocols.
  • Ensure comprehensive adherence to the Animal Welfare Regulations, Public Health Service on Humane Care and Use of Laboratory Animals (PHS Policy), applicable FDA and Center policies, The Guide for the Care and Use of Laboratory Animals (Guide), and standards set by the Association for Assessment and Accreditation of Laboratory Animal Care International
  • Revise and review all SOPs to ensure that standard procedures are performed at all times.

MINIMUM REQUIREMENTS:

  • Must have a High School Diploma or equivalent and 2-5 years’ experience in regulatory management and administration in a GLP environment is desirable. A Bachelor’s degree in a related science field is preferred.
  • Must be a Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) certification.
  • Must possess excellent organizational and communication skills.
  • Must have knowledge of laboratory animal technician duties and training.
  • Must possess excellent knowledge of Federal, State, and local regulations governing a vivarium.
  • Must have a business command of the English language both spoken and written.
Job ID: 
QAM-AR
Location: 
Jefferson, AR

Priority One Services
Priority One Services