Senior Quality Assurance Specialist
hace 4 semanas
Job Summary: We are seeking a Senior/Principal Quality Auditor to support our audit program and clinical projects. The ideal candidate will have a strong understanding of regulations and industry standards, including GCP/ICH guidelines and FDA regulations.
Key Responsibilities:
- Support the Quality Management System, including SOPs, training, and CAPA.
- Develop and administer training for employees and/or consultants.
- Host client/sponsor audits and support regulatory inspections.
- Coordinate and conduct assessments of potential and contracted vendors.
- Monitor quality systems to provide feedback on compliance risks.
Requirements:
- Minimum two to five years of applicable experience or equivalent combination of education and experience.
- Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
- Hands-on experience leading clinical site audits.
Preferred Qualifications:
- CRO, Pharmaceutical, and/or Medical device experience.
- QA certification preferred.
- Experience with electronic clinical trial systems.
About Precision For Medicine: We are a leading provider of clinical research services, dedicated to delivering high-quality results and exceptional customer service.
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