Quality Assurance Investigations Specialist
Gilbert, Arizona, United StatesAll locationsGilbert, Arizona, United StatesMesa, Arizona, United States On-site
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About the role
We are seeking an experienced Quality Assurance Investigations Specialist to join the Quality Unit at our compounding pharmacy in Gilbert, Arizona. In this role, you will lead and support investigations into quality-related events within our 503A compounding pharmacy operations. You will ensure investigations are conducted in compliance with applicable regulatory requirements, including USP <795>, <797>, and <800>. This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required. This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
What you'll bring
- 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
- Pharmacy Technician or trainee license, or willingness to obtain one.
- Strong understanding of USP <795>, <797>, and <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP
- Experience with investigations, deviation management, and escalation procedures.
- Excellent attention to detail, documentation practices, and organizational skills.
- Excellent written and verbal communication skills, including technical writing.
- Strong collaboration skills across multidisciplinary teams.
- Ability to manage multiple investigations under tight timelines.
- Proficiency in Google Workspace
- Analytical and detail-oriented mindset.
- Strong problem-solving and decision-making abilities.
- Clear and professional communication.