Quality Assurance Auditor - Core Logic, Inc.

Position Description

The Quality Assurance Auditor will contribute to management of the Company’s overall quality and compliance by performing internal and external audits, related primarily to Good Clinical Practices (GCP), and assist with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) activities as requested.


Responsibilities include the following:
• Prepare, conduct, report and follow up on audits of local and international clinical studies, ensuring compliance with GCP, applicable regulations, and company’s quality standards. These audits include, but are not limited to, investigator sites, vendor facilities, study documentation, and company systems and processes.
• Assist in internal GCP audits to ensure compliance with Company policies and procedures.
• Assist Sr. Manager QA in the information management of audits and assist in information flow between QA and functional departments.
• Respond effectively to a changing regulatory environment and assist in advising functional departments on potential GXP impacts, ensuring compliance of new and on-going programs.


Qualification:
Candidates must have a BA/BS degree from an accredited college or university with a minimum of 2-4 years of auditing experience. A degree in science or nursing is preferred; candidates with equivalent degrees in other disciplines with the required auditing experience will be considered. Required qualifications also include excellent oral and written communication skills, as well as strong organizational and time management abilities that are adaptable to a changing environment. Knowledge of GLP/GMP computer systems is a plus. Candidates must be available for business travel, both national and international, up to 50% of their time as business needs require.

Salary 80K
Travel: late ’08 & ‘09
More extensive: early in ’09
Will evenflow (in big flow right now)
Site, vendor, lab audits.

How to Apply

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