-          Developing, maintaining, and reporting performance measures and metrics

-          Review of internal documentation for compliance to SOP’s 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 Auditing

Under 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 providers

Following 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 management

Client 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