Care Access
A new vision for healthcare. Where clinical research is a patient care option.
rare diseases • pulmonology • oncology • decentralized • decentralized trials
201 - 500
Senior Quality Assurance Auditor
January 14
Care Access
A new vision for healthcare. Where clinical research is a patient care option.
rare diseases • pulmonology • oncology • decentralized • decentralized trials
201 - 500
Description
• The Senior Quality Assurance Auditor role is a key member of the Quality Assurance team and provides support to all aspects of the Quality functions across the business. • The role will support QA Management in assuring quality throughout the Company and will promote continual improvement processes to ensure all systems and procedures undertaken by Care Access are compliant with ICH-GCP Guidelines, and other applicable regulatory requirements. • This role encompass a broad spectrum of activities, ranging from auditing systems and processes to collaborating with stakeholders and contributing to the organization's overall quality and regulatory compliance objectives.
Requirements
• BSc Degree (life science) or equivalent qualification • Minimum five years’ experience in Clinical Quality Assurance within a CRO or Pharma organization or equivalent environment • Experience of performing clinical quality audits e.g. investigator site audits, process/ system audits, vendor audits. • Experience in validation of Computerized Systems would be an asset. • Experience of regulatory inspections e.g. MHRA, FDA • Experience of sponsor/CRO audit process
Benefits
• PTO/vacation days, sick days, holidays. • 100% paid medical, dental, and vision Insurance. 75% for dependents. • HSA plan • Short-term disability, long-term disability, and life Insurance. • Culture of growth and equality • 401k retirement plan
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