QA Computer System Validation Sup -GAAPR, NJ299

Job Summary

This position provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) department to maintain validation of warehouse or support systems utilized for healthcare applications. This role assesses systems being evaluated for use in healthcare applications, provides training and subject matter expertise to achieve/maintain validated status. The incumbent identifies systems requiring validation, escalates validation issues appropriately, and provides validation expertise. This position manages validation documents, determines applicable regulations, and reviews and approves testing of changes to validated systems.

The incumbent consults with internal groups (e.g., Operations, Business Development, IT, etc.) investigates and resolves healthcare issues to ensure compliance with rules and regulations. This position writes and revises Standard Operating Procedures (SOPs) and work instructions to ensure proper procedures are followed by Operations, IT or Order-to-Cash personnel. This role participates in information gathering and scheduling to prepare for internal and client audits. The incumbent assesses current SCS capabilities to determine SCS's ability to meet client requirements and proposed solutions. This position develops and revises change control procedures, training, and audits to ensure the maintenance of validation.

Responsibilities

• Writes, executes, and reviews validation protocols, generates validation reports, and performs corrective actions for deviations to provide subject matter expertise for SCS in validation matters
• Reviews policies, procedures, and regulations with internal/external clients to determine specialized requirements and ensure compliance
• Coordinates document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data are maintained in an orderly manner and meet quality standards
• Leads validation personnel or projects, when assigned
• Records information and observations from internal audits to support the preparation and distribution of internal audit reports
• Establishes and maintains quality policies and programs within the IT area to ensure proper document and data control methods are utilized
• Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities
• Interacts with internal auditors to discuss audit plans and findings
• Ensures continued learning of new/existing regulatory requirements by the various regulatory bodies governing our healthcare industries
• Participates in consultations with Corporate Legal to determine compliance implications of pending business
• Ensures consistent and timely completion of compliance-base tasks as assigned including but not limited to NCs, CAPAs, Audit findings and Document Changes/Management
• Follows up with clients after audits to identify issues and mutually acceptable solutions

Preferences

• 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
• Utilizes conflict management skillsets to resolve any unforeseen departmental and cross-functional conflicts and issues
• Captures/documents specific/accurate information; learns subjects thoroughly and in detail; completes work with thoroughness; supplies details when requested and maintains organized files
• Applies established procedures for responding to incidents; determines and documents information pertinent to incidents; communicates resolutions or results to stakeholders
• Demonstrates an 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
• Possesses basic knowledge of risk management fundamentals; understands supply chain concepts; identifies issues within a supply chain; uses the appropriate style, level of detail, grammar, and organization of thought in technical writing
• Drafts standard specialized or technical documents using templates and job aids; considers the end-user’s perspective when creating technical documents
• Makes minor adjustments to test plans; recognizes the importance of quality assurance to the business; identifies conditions that impede the quality assurance process
• Demonstrates an understanding of technology used by the company; communicates basic technological concepts/terminology and applies standard technology in daily work
• Bachelor's Degree (or internationally comparable degree) in Computer Science, Information Systems or related field - Preferred
• Possesses knowledge of Supply Chain logistics 
• Experience in the Healthcare industry