QA Auditor I

DEPARTMENT: Quality Assurance/Regulatory Compliance

REPORTS TO: QAU Management (Supervisor or above)


Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under direct immediate supervision. Typically reports to a supervisor or above.

  • Review/audit study (GLP) data, SOPs, and other research data in support study reports.
  • Perform scheduled internal and vendor audits, produce Quality Assurance Inspection Reports with supervision.
  • Read and understand documentation for new and current compliance procedures and regulatory enforcement trends/actions.
  • Demonstrate ability to work accurately, follow instructions/schedules/timelines.
  • Apply knowledge of FDA, and/or OECD and cGxP regulations and guidelines.
  • Education:
    • Bachelor’s degree in area of specialty and 0-2 years of direct experience in the field related area; or
    • High School degree or equivalent with a minimum of 4 years experience in a GXP environment and 1-2 years direct QA experience.
  • Accountability – Ability to accept responsibility and account for his/her actions.
  • Communication, Oral – Ability to communicate effectively with others.
  • Communication, Written – Ability to communicate in writing clearly and concisely.
  • Decision Making – Ability to make critical decisions with supervision.
  • Detail Orientation – Ability to pay attention to the minute details of a project or task.
  • Organization – Possessing the trait of being organized or following a systematic method of performing a task.
  • Computer Skills – General computer skills including Microsoft Word, Excel, and PowerPoint.
  • Animal facility and laboratories with moderate noise possible.
  • Exposure to hazardous/noxious devices (e.g., needles, scalpel blades etc) and chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc).
  • General office working conditions, with generally quiet noise conditions
  • This position may require occasional duties on weekends and/or holidays.

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

If you are interested in this opportunity please send your CV to