RA / QA Auditor

Internal Auditor

Position at Prismatik

Essential Functions :

• Executes the full lifecycle of audit program(s), including but not limited to developing audit schedule, leading and conducting audits, assessing and reporting results, managing timely responses, and following up on corrections, corrective and / or preventive action items, and verification of effectiveness.
• Conducts audits in a timely manner according to the audit schedule. Reviews containment actions, performs thorough investigations, determines root cause, and develops action and verification of effectiveness plans.
• Interprets recommendations, observations, and findings from audits to ensure corrective actions are appropriate and effective. Informs stakeholders of potential risks.
• Collects and analyzes data to measure effectiveness of audit programs relative to department goals and objectives.
• Partners with process owner to perform verification and assess effectiveness of audit action items.
• Maintains and regularly updates audit tracker to monitor audit status and progress.
• Develops quality and audit metrics and reports, such as PARETO charts and / or control charts, to track audit trends and effectiveness.
• Coordinates and leads stakeholder meetings to ensure visibility into audit statuses and activities. Presents results to stakeholders for alignment and to identify improvement opportunities.
• Participates in supplier audit as part of critical supplier selection and evaluation.
• Presents and distributes internal audit reports including action items from audit results.
• Coordinates and manages onsite audit preparations, including logistics and other audit readiness activities. Participates in third party audits.
• Escalates and supports audit process owner by issuing an audit, Corrective and Preventive Action (CAPA), and / or non-conformance report (NCR) extension request when applicable to prevent a past due record.
• Reviews and approves quality records for compliance, content, completion, accuracy, and relevancy to the subject matter. Ensures records adhere to all applicable procedures, guidance, regulations, and standard requirements.
• Reviews Quality System elements to assess its adherence to the criteria for management and control processes.
• Participates in improvement projects for the Quality Management System (QMS).
• Coordinates and partners with impacted teams to provide guidance on manufacturing processes or quality systems compliance.
• Stays abreast of relevant domestic and international standards and regulations to monitor and ensure conformance.
• Acts as a liaison between internal audit and regulatory agencies, suppliers, and internal teams to facilitate clear and effective communication.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications :

Pay range : $75,035 - $95,000 / yr. Exact compensation may vary based on skills and experience.