Quality Compliance Specialist

3 weeks ago

Orlando, United States Olympia Pharmaceuticals Full time

General Purpose

The Quality Compliance Specialist position is responsible for conducting all investigations in the Sterile and Non-Sterile compounding departments, the shipping and receiving area, and all product related investigations. This position works closely with the Sterile and Non-Sterile Pharmacists and supports the Quality Department in investigation of product related events, Out of Specification Conditions (OOS), Out of Specification Monitoring, Deviation Writing, Analyzing and Tracking Data, and Root Cause Analysis. This position performs routine and random audits of all processes and procedures for compliance with internal requirements and external regulations. Auditing areas of focus include Sterile Compounding, Non-Sterile Compounding, Dispensing, Shipping, Receiving, and other areas as assigned.


Job Tasks and Responsibilities


  • Ensures all work is performed in compliance with Standard Operating Procedures and relevant regulatory requirements including USP 795, USP 797, and USP 800.
  • Conducts root cause analysis and implements solutions in collaboration with the department manager.
  • Write and review deviations, out of specification result investigations, and CAPAs.
  • Monitors all investigations for progress to timeline.
  • Communicates investigation delays to the Quality Manager and Pharmacy Manager
  • Performs effectiveness checks to ensure CAPAs have been adequately implemented and are effective.
  • Communicates investigation findings to Quality Assurance, the Quality Manager, and the Pharmacy Manager for data tracking, trending, and follow up as needed.
  • Conducts periodic review of Quality metrics and analyzes trends.
  • Works in collaboration with the Sterile Compounding Pharmacist(s), Non-Sterile Compounding Pharmacist(s), and relevant department managers to schedule and complete all investigations.
  • Performs all internal audits in compliance with Standard Operating Procedures in collaboration with Quality Assurance.
  • Communicates and schedules internal audits to ensure completion within current Standard Operating Procedure requirements and to maintain compliance with all regulatory requirements including with state licensing as required.
  • Prepare auditing tools to review items and areas of inspection.
  • Define and Propose auditing scope to the Quality Manager and Pharmacy Manager.
  • Identify and incorporate the internal standards and external standards for inclusion in the prepared auditing tool.
  • Schedule auditing activities with the required departments, auditing team members, and participants to comply with deadlines and production needs.
  • Develop checklists, and other related working papers and data collection methods.
  • Clearly define audit goals and objectives and communicate these objectives to the audit recipient(s).
  • Select and propose audit team members with the knowledge and expertise required to conduct the area to be audited. Coordinate with the Quality Manager and Pharmacy Manager for approval of the team members.
  • Select and propose the resources required to conduct the audit as required by the area of focus. Coordinate with the Quality Manager and Pharmacy Manager for approval of the required resources.
  • Conduct a detailed technical review of all processes and procedures.
  • Obtain and review all required Quality and Pharmacy related documentation as applicable to the scope of the audit.
  • Educate and train audit recipients to close gaps identified within audits.
  • Takes on special projects as assigned and other delegated duties.
  • Maintain patient confidentiality in accordance with HIPAA.
  • Participates in training as necessary.
  • Attends company/departmental meetings as well as educational programs as required.


Education and Experience Requirements

  • High school diploma.
  • 2+ years of post-high school education desirable.
  • 2+ years with pharmacy compounding experience.
  • Experience may be substituted for education at management’s discretion.
  • Excellent communication and interpersonal skills to deal with a diverse customer group.
  • Experience implementing preventative measures and performing effectiveness checks.


Education and Experience Preferred

  • College Degree in a science related field.
  • Familiarity with the following Quality principals and tools: DMAIC, Root Cause Analysis tools (Ishikawa Diagram, 5-whys, 8D).
  • 2+ years prior auditing experience in a facility regulated under the FD&C Act and/or a cGMP compliant facility.
  • Auditing certification by a recognized independent organization such as ASQ.
  • Ability to host professional meetings and internal presentations.


Schedule:


  • 8 hour shift
  • Monday to Friday 9am - 6pm

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