In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• It ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards
• Conducts internal audits of the Quality System for the purpose of verifying compliance with government regulations and applicable standards, in addition to company policies and procedures. Conducts good laboratory practice (GLP) audits as required.
• Gives guidance or advice as it relates to compliance with applicable standards and regulations.
• Performs re-audits to deficient aspects and to implement corrective and preventive actions as necessary and required.
• Assigns classifications to internal audit observations and documents audit results in written reports that can be distributed and reviewed by appropriate management.
• Monitors the effectiveness of corrective actions documented in observation responses.
• You can be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/or volunteer auditors.
• Reviews ownership of responses to audit observations, also acts as an advisor to other areas that are not being audited by him/her, giving advice on audit observation responses.
• Maintains audit report files, re-audit files and responses to audits carried out.
• Accompanies external auditors, representatives of government agencies or those required by management during the execution of an applicable audit.
• Conducts audits at other J&J sites when required by management.
• Complies with and reviews compliance metrics and communicates them to site management and the Franchise. Prepares information for Management review boards.
• Participates in the formulation of Regulatory Policies and Procedures in compliance with applicable local, state and federal standards and regulations through the development of Franchise Documents.
• It is kept up to date on government regulations and applicable standard changes through publications, participation in seminars or by collaboration with organizations.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed