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- Newark, DE
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Quality Assurance System Validation Specialist
UPS • Newark, DE
Posted 27 days ago
The Healthcare Quality Assurance (QA) Validation Specialist is responsible for assisting with computer system validation activities and compliance with regulatory requirements in UPS Supply Chain Solutions healthcare computer systems. He/She assists QA Validation Supervisors with system validation projects that involve evaluating healthcare applications, hardware/software, and systems. This position assists with the review and approval of validation tests on hardware/software and systems. The Healthcare QA Validation Specialist manages computer system validation documentation (i.e., organizing, photocopying, scanning, and distributing documentation to healthcare facilities) in compliance with regulatory agencies. He/She will review change control documentation and assess potential changes to validated systems to determine if re-validation testing is required. This position maintains and tracks Corporate Standard Operating Procedure (SOP) training for the Validation group. The Healthcare Quality Assurance Validation Specialist conducts research for acquiring new validation testing and monitoring equipment. He/She provides administrative support and project assistance to the Validation group as needed to achieve validation objectives. The Healthcare Quality Assurance Validation Specialist reports to a Validation Supervisor.
This position drafts and updates validation master plans to provide current milestones and objectives to client healthcare distribution centers. The Healthcare QA Validation Specialist facilitates validation testing of chambers, equipment, and systems to execute test steps as stated in validation test protocols. He/She maintains calibration certificates of testing equipment and applicable vendor qualification documentation to meet respective agency requirements.
- Generates project status reports to communicate project goals, contingency plans, and issue resolutions to project teams and clients.
- Ensures necessary SOP training is completed in a timely manner to ensure appropriate procedures are followed in accordance with UPS quality standards.
- Conducts research to investigate new testing methods and techniques for complex and unusual validation projects.
- Works with Information Technology Quality Assurance (ITQA) to review and approve Information Technology (IT) test scripts
- Provides data to decision makers to make recommendations that impact the Validation group.
- Conducts Research: Identifies the business problem that requires research; identifies sources of information that are relevant to a problem; reviews literature and data related to the research question; summarizes information from data sources.
- 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.
- Legal, Regulatory, and Compliance Knowledge: Demonstrates a basic understanding of the functions, regulations, and procedures of compliance agencies or governing bodies; takes a leadership position in programs that reduce risk and enhance safety.
- Quality Assurance Knowledge: Communicates quality assurance methodology and explains desired outcomes of testing; identifies the steps in the project life cycle.
- Report Generation: Possesses ability to generate simple reports using basic functions in software, and/or writing basic queries; identifies information required to complete reports and identifies existing reports generated by others.
- Technology Knowledge: Demonstrates a general understanding of technology used by the company; communicates basic technological concepts and terminology; applies standard technology in daily work.
- Associate’s Degree - Preferred
- Associate’s Degree – computer related field – Preferred
- FDA/DEA business related experience - Preferred
Employer will not sponsor a visa for position.
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