Quality Assurance Compliance Specialist

4 weeks ago


Orlando, United States Apple & Associates Full time

Quality Assurance Specialist I - Supplier Quality emphasis


Join our client's dynamic pharmaceutical team as a Quality Compliance Specialist in sunny Orlando, FL, dedicated to excellence in healthcare solutions


Quality Specialist Benefits:

  • M-F 9-6 hours, no off shifts or weekends
  • Comprehensive health and 401(k) programs.
  • Professional development opportunities within pharmaceutical manufacturing
  • Vibrant company culture in a convenient Orlando location.


Quality Compliance Specialist Responsibilities:

  • Conduct investigations for sterile and non-sterile pharmaceutical compounding, shipping, receiving, and product-related events.
  • Collaborate with department managers for root cause analysis and solution implementation.
  • Write and review deviations, out-of-specification investigations, and corrective and preventive actions (CAPAs).
  • Monitor investigation progress and communicate delays to management.
  • Perform effectiveness checks to ensure CAPAs are implemented successfully.
  • Communicate investigation findings for data tracking and trend analysis.
  • Conduct routine audits of processes and procedures for compliance.
  • Collaborate with pharmacists and department managers to schedule and complete investigations.
  • Conduct internal audits in compliance with SOPs and regulatory requirements.
  • Develop auditing tools, define auditing scope, and schedule auditing activities.
  • Educate and train audit recipients to address identified gaps.
  • Undertake special projects and delegated duties as assigned.

Quality Compliance Specialist Requirements:

  • High school diploma required; post-high school education preferred.
  • 2+ years of pharmacy or pharmaceutical compounding or manufacturing experience.
  • Excellent communication and interpersonal skills.
  • Experience in implementing preventative measures and performing effectiveness checks.

Quality Compliance Specialist Preferred Qualifications:

  • College degree in a science-related field.
  • Familiarity with quality principles and tools such as DMAIC and Root Cause Analysis.
  • 2+ years of prior auditing experience in a regulated facility.
  • Auditing certification by a recognized organization such as ASQ.
  • Ability to host professional meetings and presentations.



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