Sr. Auditor (Clinicals) Job in Boston, Massachusetts US
ClearBridge Technhology group is assisting our client (Provider of technology solutions used in Clinical Trials) with hiring a full time Sr. Auditor.
Project Overview: The Sr. Auditor primarily serves as a lead auditor under the procedures outlined in our clients Quality Management System.
Additional responsibilities would include, but not be limited to: - Developing, maintaining, and reporting performance measures and metrics - Review of internal documentation for compliance to SOPs and applicable regulations- Participating in process improvement projects- Review and resolution of QMS defects and CAPA Plans- Assisting Quality Management with response to audits by customers and other external auditors Roles & Responsibilities: Internal AuditingUnder the direction of Quality Management, conduct audits of internal systems, tools, and functions as well as external suppliers for compliance with client's Standard Operating Procedures and external Regulations.
Such audits include but not limited to: Clinical Trial development, implementation, and archive Core software products Internal systems Internal software tools External providersFollowing the execution of the audit, the Quality Systems Specialist will Track and report quality concerns and problems to Quality Management Participate in audit follow up, and Corrective Action procedures Act as a resource to staff and managementClient Auditing Function as the primary contact point for client auditing of our quality systems.
Planning and preparation of audits Developing actions plans and follow-up Hosting of client auditors Support Sales and Marketing in developing RFI and RFP Supplier Management - Maintaining overall supplier management program- Auditing of supplier operations Required skills: (MUST HAVEs)· 2-5 years experience in quality systems management, including training and experience with Clinical Trials and auditing· Knowledge of GCP and international Quality/Regulatory Rules, Standards, Guidelines· Computer literacy and familiarity with most common software applications such as Microsoft Office applications· Able to follow written procedures accurately· Possess strong communication skills· Work well both independently and as a team player
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