Clinical Quality /GCP Quality Assurance Auditor
Purpose: To describe the CPI expectations for the position of a Clinical Quality Associate / GCP Quality Associate Description:
Reporting to the Manager of Quality Assurance, the GCP Quality Associate responsibilities include but are not limited to:
a.Create and review company SOPs and cultivate continuous improvement processes and procedure to ensure a robust QMS b.Conduct internal processes/systems audits ensuring findings are addressed c.Generate audit reports to project teams, management, and participate in trend analysis to identify and help rectify repeat audit findings. d.Conduct external clinical investigator site audits and vendor organization audits. e.Participate in GCP Inspection readiness activities. Provide report to internal or external client on findings and recommendations. f.Assist in quality assurance and quality control of overall internal compliance, i.e., Regulatory Requirements and Client and CPI SOPs as applicable g.Ensure continuous improvement of policies, procedures, and training Qualifications: Bachelors Degree preferably in a scientific discipline with Quality Assurance certifications AND a minimum of three (3) years’ experience conducting Quality Assurance audits of internal process & external clinical site audits (or vendor) in a quality assurance and quality control environment. Or a Bachelor’s Degree in a scientific discipline AND a minimum of 7 years’ experience conducting Quality Assurance audits of internal process & external clinical site audits (or vendor) in a quality assurance and quality control environment Ability to travel 30% of the time; both domestic and international. Skills: ·Demonstrated knowledge and understanding of ICH guidelines, FDA and international regulations as well as clinical research and development and clinical manufacturing processes. ·3-5 years of Quality Assurance auditing experience ·Training presentation and preparation in Regulated Environment ·Preparation and oversight of Procedural Documentation including Audit Reports ·Excellent communication skills ·Ability to work independently and with internal/external (client) personnel ·Address complex projects and problems confidently and professionally
- Knowledgeable regarding the use of the Company’s computer system, and MS suite and other office computer software programs.
·Able to handle several tasks and assignments simultaneously ·Organized and able to manage time efficiently