Quality and Regulatory Affairs Auditor
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We are looking for a QA Auditor to join our Quality Assurance team and support the continuous improvement of our Global Quality Management System (QMS). In this role, you will conduct and coordinate audits, support regulatory and customer inspections, manage audit findings and CAPAs, and ensure compliance with applicable international standards and regulations.
Position responsibilities
- Plan and conduct internal, customer, supplier, and regulatory audits.
- Coordinate customer audits and inspections, including preparation, communications, and follow-up.
- Manage audit findings, CAPAs, and corrective actions through timely resolution.
- Support compliance with standards including ISO 9001, ISO 17100, ISO 27001, GxP, and other applicable regulations.
- Analyze audit data and prepare trend reports for management.
- Support the development and continuous improvement of QA programs, processes, and the QMS.
- Collaborate with clients, auditors, vendors, and internal stakeholders to ensure effective audit outcomes.
- Stay current with regulatory and industry requirements.
- Travel domestically and internationally as required.
Requirements
- Bachelor's degree or equivalent.
- Excellent written and verbal English communication skills.
- 2+ years of experience in the Life Sciences industry, with QA/audit experience.
- Experience with QA, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
- Experience with internal, customer/sponsor, and/or regulatory audits.
- Knowledge of ISO 9001, ISO 17100, ISO 27001, GxP, ICH E6, and/or 21 CFR Part 11 is a plus.
- Strong analytical, problem-solving, organizational, and interpersonal skills.
- Ability to manage multiple audits and projects in a fast-paced environment.
- Proficiency in Microsoft Office.
Preferred
Lead Auditor certification, experience in regulated industries, Lean/Six Sigma knowledge, and fluency in an additional language.
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