Compliance Coordinator

20 hours, 30 minutes ago
Full-time
Junior
Operations
Empower Pharmacy

Empower Pharmacy

Empower Pharmacy operates as a 503A compounding pharmacy and FDA registered 503B facility, specializing in the production of high-quality, personalized medications to enhance the health and well-being of patients across the United States.

Health Care Providers & Services
251-1K
Founded 2009

Description

  • Coordinate and track cross-functional compliance initiatives, ensuring timelines, deliverables, and documentation align with regulatory requirements.
  • Support implementation and maintenance of compliance programs across 503A and 503B operations.
  • Translate regulatory requirements into actionable tasks across departments.
  • Maintain awareness of FDA, DEA, USP, and State Board of Pharmacy regulations and communicate updates to stakeholders.
  • Maintain an inspection-ready compliance library, including licenses, permits, SOPs, training records, vendor documentation, audit reports, and CAPA records.
  • Support controlled document management, including versioning, accessibility, and archival.
  • Coordinate mock audits, track readiness metrics, and support inspection readiness activities.
  • Retrieve and organize requested records during regulatory inspections and internal audits.
  • Track employee licensure and certification statuses, and monitor facility licenses, permits, and renewals.
  • Assist with compliance-related communications, training logistics, reporting, dashboards, and administrative support.
  • Use AI tools and automated dashboards to support regulatory research, tracking, and compliance reporting.

Requirements

  • Working knowledge of 503A and 503B regulatory frameworks.
  • Knowledge of USP 795/797/800 standards, FDA guidance, DEA requirements, and State Board of Pharmacy regulations.
  • Experience supporting compliance activities such as internal audits and documentation review.
  • Ability to assist with drafting regulatory responses, CAPAs, and root cause analysis under leadership guidance.
  • Familiarity with leveraging technology, including AI tools, for regulatory research and documentation.
  • Detail-oriented, process-driven mindset with a focus on SOPs, compliance tracking tools, and training support.
  • Ability to monitor licensure, certification, and renewal tracking for employees and facilities.
  • Ability to support inspection readiness and maintain organized, audit-ready records.
  • Physical ability to talk, hear, sit for long periods, and move around an office/campus environment.

Benefits

  • Medical, dental, and vision coverage.
  • Paid time off.
  • 401(k) matching.
  • Wellness perks.
  • IV therapy benefit.
  • Compounded medications benefit.

Interested in this position?

Apply directly on the company website

Apply Now

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