Job Description

Role Description
(Please note that a single position may include multiple roles.)
Organization
R&D Quality J&J Innovative Medicine
R&D Quality Group
Quality Assurance
Role
Auditor
Level
( Scope, responsibilities and ownership will increase with level.)
Specialist
PRINCIPAL RESPONSIBILITIES:
Main responsibilities will include but are not limited to:
Auditing
\xc2\xb7 Leads the planning, conduct and reporting of R&D Quality QA routine audits and supports non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated areas to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
\xc2\xb7 Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
Inspection Support
\xc2\xb7 Supports regulatory inspections in various supporting roles.
Training & Development
\xc2\xb7 Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
\xc2\xb7 May assist in the preparation of training material if requested.
People Management
\xc2\xb7 N/A
Project Management
\xc2\xb7 Participates in projects or serves on teams, as assigned by supervisor.
\xc2\xb7 Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
Qualifications
Subject Matter Expert / Point of Contact
\xc2\xb7 Provides consultation to business partners on routine tasks with occasional supervision. Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.