Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Payrate: $53.00 - $55.00/hr summary:
We are seeking an experienced Senior Quality Assurance Specialist to support SAP S/4

HANA transformation initiatives and implementation across complex enterprise environments. The ideal candidate will bring strong QM module knowledge, project management experience, Quality Assurance process understanding, ERP implementation knowledge, and the ability to coordinate cross-functional teams through design, build, testing, deployment, and stabilization.

Responsibilities

• Lead Quality Assurance (QA) business activities for the design, implementation, testing, testing approvals, deployment, and stabilization of the SAP S/4
  
  HANA Quality Management (QM) module within a regulated manufacturing environment.
• Serve as the Quality business lead back-up and SAP QM subject matter expert, partnering with Quality Business Process Owners, site Quality organizations, SAP functional teams, DTI, Validation/Computer Software Assurance (CSA), and implementation partners to translate Quality and regulatory requirements into scalable SAP QM solutions.
• Lead SAP QM fit-to-standard and solution design activities across core Quality processes, including incoming material inspection, in-process inspection, finished product inspection, inspection at goods receipt, stock transfer, and other relevant inspection scenarios.
• Define business requirements and design decisions for SAP QM inspection processing, including inspection types, inspection lot creation and processing, inspection plans, master inspection characteristics, sampling procedures, results recording, defects recording, usage decisions, and quality stock disposition.
• Partner with Master Data teams to define Quality master data ownership, creation and approval processes, data standards, migration rules, cleansing requirements, mapping, transformation, load validation, and post-migration verification.
• Ensure appropriate integration of Quality inspection and inventory processes, including goods receipt inspection, Quality Inspection stock, blocked/restricted stock, inspection lot processing, usage decision, stock posting, material movement, batch status, and disposition.
• Define Quality requirements associated with batch-managed materials, including batch characteristics, classification, inspection results, batch status, shelf-life considerations, and Quality-related release and disposition controls.
• Review functional specifications, configuration documentation, process flows, user requirements, functional requirements, interface requirements, reports, forms, workflows, and technical design documentation to ensure alignment with approved Quality business requirements.
• Partner with DTI and technical teams to define and verify QM interfaces and integrations with manufacturing, laboratory, warehouse, serialization, document management, reporting/analytics, and other Quality systems, as applicable.
• Lead and support QA business participation in end-to-end testing and validation of SAP QM functionality, including System Integration Testing (SIT), User Acceptance Testing (UAT), regression testing, interface testing, negative testing, role/authorization testing, and business process qualification.
• Lead Quality defect triage and resolution by assessing SAP QM defects for business and compliance impact, determining appropriate prioritization, supporting root-cause analysis, reviewing proposed solutions, and ensuring appropriate retesting and closure.
• Ensure SAP QM implementation activities comply with applicable GxP requirements, data integrity principles, electronic records/electronic signature requirements, internal Quality Management System requirements, and computerized system validation/assurance standards.
• Assess changes to existing Quality processes, SOPs, work instructions, forms, records, roles, and controls resulting from SAP QM implementation and coordinate required Quality documentation updates.
• Support SAP QM cutover planning and execution, including Quality master data migration, open inspection lots, Quality stock, batch status, transactional data, interfaces, user access, and other Quality-critical cutover objects.
• Define and assess Quality Go-Live readiness criteria and support Quality approval of deployment based on completion of testing/validation, defect resolution, data readiness, SOP readiness, training completion, access readiness, cutover execution, and applicable compliance requirements.
• Lead Quality support during Hypercare and post-Go-Live stabilization, including SAP QM issue triage, Quality impact assessments, defect prioritization, data/process reconciliation, root-cause investigation, corrective actions, and transition to steady-state support.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Information Systems, Manufacturing, Operations Management, Business, or a related field.
• 10 years of experience in Quality Assurance, Quality Systems, Quality Operations, Manufacturing Quality,…