Senior Quality Assurance Investigator

5 days ago


Houston, Texas, United States Empower Pharmacy Full time
Job Summary

The Principal Quality Investigator at Empower Pharmacy plays a pivotal role in ensuring the highest standards of quality and compliance across our 503A and 503B operations.

Key Responsibilities
  • Manages all ongoing investigations for 503B to ensure timely closure.
  • Analyzes, prepares, and presents trending analysis to middle, senior, and executive leadership.
  • Leads cross-functional teams to resolve complex investigations and those with significant potential impact to the organization.
  • Develops, implements, and executes a training program to teach and certify employees to write effective investigations.
  • Aligns and communicates investigation priorities across multiple functions.
  • Reviews and approves investigations as the quality representative.
  • Understands and presents investigations and investigation trending during regulatory inspections.
Requirements
  • Bachelor's degree in science or related field.
  • Minimum 5 years of experience in Quality Assurance/Control Operations or a related field in the healthcare industry required.
  • Minimum of 3 years experience working with pharmaceutical investigations, conducting root cause analysis, and technical writing.
  • Experience with 503A compounding regulations, 503B outsourcing regulations, USP 795, USP 797, and USP 800 preferred.
What We Offer
  • No-cost medication for employees.
  • Comprehensive medical, dental, and vision options.
  • Telehealth visits.
  • Paid and volunteer time off.
  • Flexible scheduling options.


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