Sr. Specialist Quality Assurance (QA)

Let's do this. Let's change the world. In this vital role you will

Serve as Subject Matter Expert for disposition QA roles, disposition transactions, and Quality Master Data in SAP. Provide assessment, guidance, review, and approval for disposition processes and Quality Master Data in SAP to ensure completeness and accuracy, sound rationale, and alignment to regulatory expectations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management's attention and initiate and implement necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of deviation requests related to SAP. Participate in and support regulatory inspections.

• Provide business assessment on impact from SAP system changes related to disposition and Quality Master Data
• Provide guidance on setup of Quality Master Data in SAP
• Own relevant controlled documents including SOPs, forms, guidelines, and specifications related to SAP functionality, transactions, reports, functionality, and roles
• Review operational SOP's and Work Instructions related to SAP
• Approve access for SAP QA Roles from sites and review user access roles to ensure segregation of duties and no excess access
• Own SAP QA training material
• Initiate, own, or support as QA approver QA Deviations (Major, Minor) and CAPAs as needed
• Review and approve Data Integrity Assessments
• Support the Global Network for Disposition Process and Global Raw Material Sampling and Inspection
• Help to solve production issues related to Quality Master Data, disposition processes, Quality SAP reports, reclassification, sampling, posting of stock, shipments and movement of materials to various stock statuses
• Support inspections/audits related to Quality Module and batch numbering scheme in SAP
• Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Trend data
• Anticipate and prevent potential problems
• May be responsible for specific programs and/or projects
• Independently develop solutions that are thorough, practical and consistent with functional objectives

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Bachelor's degree in computer science or related field and 5+ years of Software and Systems Quality assurance experience
• 10 years of demonstrated ability working directly with SAP and performing business assessments related to system changes
• Deep Technical knowledge of SAP, SAP disposition functions, and Quality Master Data in SAP
• Experience owning and serving as QA Contact for Major and Minor Deviations
• Ability to interpret and apply GLPs, GCP's and GMPs
• Knowledge of industry and business principles
• Demonstrated problem solving abilities
• Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
• Provides training and guidance to others
• Extends capabilities by working closely with senior staff/ experts within and outside the internal organization