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QA CAPA Supervisor (NA) - Flex location

Morris Road Location Primary Location: LOUISVILLE, KY - United States Facility Morris Road Location Job ID 184004 Zip Code 40219
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The Healthcare (HC) Quality Assurance (QA) Corrective Action Preventive Action (CAPA) Supervisor is part of the HC Compliance Governance team. He/She is responsible for developing and maintaining the UPS Supply Chain Solutions (SCS) Global HC non-conformance (NC) and CAPA policies and procedures as well as monitoring, reporting and communicating issues, trends, risks and performance to UPS SCS senior management. The HC QA CAPA Supervisor trains staff, provides expertise and reviews NC documentation. He/She also review NC records across the UPS SCS HC network to identify trends and risks that need to be prevented through the Global CAPA program. The HC QA CAPA Supervisor reports to the Global Governance Senior Manager responsible for CAPA and Complaints. This position may include travel within US and Canada on a regular basis.

Responsibilities and Duties

  • Assists in development and maintenance of the NC and CAPA handling procedures to ensure continual compliance to regulatory, internal and customer expectations
  • Facilitates monitoring and communicating NC and CAPA trends, risks and process performance of UPS SCS HC operations
  • Facilitates potentially critical severity NC event triage process for UPS SCS HC operations
  • Reviews NC and trains staff on how to effectively review, assess and document NC events through fact finding, conducting investigations and root cause analysis, evaluating risks, developing corrective actions and establishing effectiveness checks
  • Assesses NC events across the UPS SCS HC operations for risk impact and escalation to CAPA process

Knowledge and Skills

  • Detail Orientation: Captures/documents specific and accurate information; learns subjects thoroughly and in detail; completes work with thoroughness; supplies appropriate details when requested; maintains organized files
  • Analytical skills (science/research or data analysis experience, training or education)
  • Critical thinking and problem solving skills (science, investigations, complex problem solving or Quality/QA experience, training or education)
  • Technical Writing: Demonstrates a general understanding and use of grammatical rules; expresses ideas clearly and concisely; explains the relationship of effective writing to business objectives
  • Communication skills (strong written and verbal – able to communicate at both highest and lowest levels of UPS SCS organization – strong technical writing skills)
  • Demonstrated organizational and time management skills
  • Strong understanding and experience working with the various components of Quality Management Systems & cGMP requirements
  • Previous experience in investigations, program/project management or quality oversight in cGMP/healthcare environment
  • Previous QA experience in a cGMP/ISO/healthcare environment 
  • Bachelor’s Degree (or internationally comparable degree) in a technical discipline such as Science or Engineering - Preferred

UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law
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