Quality Auditor and CAPA Sepcialist
Location:
Frisco , Texas
Posted:
February 03, 2017
Reference:
00001HCZ
POSITION SUMMARY:
In partnership with the CSRA Manager/Director, the Quality Auditor and CAPA Specialist is responsible for performing the CSRA quality audit processes and Corrective Action / Preventive Action program activities within the AmerisourceBergen Specialty Group business units.

PRIMARY DUTIES AND RESPONSIBILITIES:
Perform Internal Audits:
  • Perform internal audits to ensure alignment of business unit with the Quality Management System standards, internal policies and procedures, applicable regulations, and accreditation standards.
  • Generate audit documentation including but not limited to: audit checklist, audit agenda, audit summation, audit report(s).
  • Provide recommendations and data required for development of an annual risk-based internal auditing schedule.
  • Provide consultation on corrective and preventive actions performed as a result of internal audit observations.
  • Follow-up and provide data required for key performance metrics related to internal audit performance and continuous quality improvement.
  • Recommend organizational process improvement initiatives based on internal audit observations.
Perform Vendor, Contract, Payer and Accreditation Audits:
  • Perform vendor, contract, payer and accreditation audits/surveys as scheduled/ requested to ensure compliance with applicable Quality Management System standards and regulations.
  • Ensure requested timelines are documented and met.
  • Generate audit documentation including but not limited to: audit checklist, audit agenda, audit summation, audit report(s).
  • Assist in the development and implementation of audit presentation materials.
  • Follow-up and provide data required for key performance metrics regarding audit findings related to performance and continuous quality improvement.
  • Recommend organizational process improvement initiatives based on audit observations.
Perform CAPA Program Activities:
  • Be able to: Identify quality issues, perform investigative research, determine root cause analyses, and document corrective action and preventive action plans.
  • Follow-up and provide data required to determine the timeliness and effectiveness of corrective and preventive actions performed.
  • Follow-up and provide data required for key performance metrics related to the CAPA program and continuous quality improvement.
  • Follow-up and provide data required for data trending and analysis to monitor and report on the effectiveness of the Quality Management System.
  • Evaluate the efficacy of completed CAPA plans.
  • Recommend organizational process improvement initiatives based on CAPA data analysis.



Qualifications:
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
Bachelor's degree in healthcare or related field preferred, plus 3 years related audit experience or formal investigation/problem-solving experience in a specialty pharmacy industry, or an equivalent combination of education and experience.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:


Technical Proficiencies
  1. Strong understanding of Quality Management System concepts as they relate to specialty services (HUB, Home Health, Pharmacy, and Coordination of Care)
  2. Mathematical competence to computate compliance rates. Ability to analyze data to create, charts, graphs, and table to represent results of audits/outcomes. Competency in formal problem-solving techniques.
  3. Strong understanding of Six Sigma and/or Lean methodology.
  4. Avanced proficiency in MSOffice software suite including Word, Excel, PowerPoint, and Visio.
  5. Preferred understanding of FDA regulations 21 CFR Part 11, 21 CFR Part 208, 21 CFR Part 600.80, 21 CFR Part 314.80, 21 CFR Part 312.33, and 21 CFR Part 50, USP 797, TX/CA/CO/MD/PA Home Health standards, Board of Pharmacy rules and regulations for all 50 States

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