Senior Quality Assurance Auditor, Quality Assurance - San Diego, CA - Quintiles Transnational (San Diego, California)

City: San Diego
State: California
Country: USA

Company Name: Quintiles Transnational
Job Category: Other

The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are seeking an enthusiastic Senior Quality Assurance Auditor to join our team!
 
Sr QA Auditor will plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures; prepare and distribute reports of findings to supervisor, operations staff, management, and customers; provide consultation in interpretation of regulations, guidelines, policies, and procedures; support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
 
Responsibilities:

• Planning, scheduling, conducting, and reporting audit in any of the countries involved with Quintiles contracts. 
• Evaluating audit findings and preparing and distributing reports to operations staff, management, and customers.
• Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• Preparing, reviewing and approving corrective action plans, following implementation of corrective actions and closing audits.
• Presenting educational programs and providing guidance to operational staff on compliance procedures.
• Evaluating policies and procedures for compliance with applicable regulations/guidelines and providing recommendations to management for continuous process improvements.
• Hosting customer audits.
• Assisting in hosting regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed.
• Assisting in training of new Quality Assurance staff.

Locations:  We are open to having candidates in any of the following three offices;  Research Triangle Park, NC, Parsippany, NJ or San Diego, CA
Bachelor's degree and 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GXP and GCP experience; or equivalent combination of education, training and experience.
 

• Knowledge of word-processing, spreadsheet, and database applications. 
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.