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Job Title: Senior Auditor, QA&C
Job Location: NJ: Princeton
Pay Rate: Open
Job Length: full time
Start Date: 2008-07-11
Company Name: Covance
Contact: HR
Phone: email only please
Fax: email only please
Description: Business Title Senior Auditor, QA&C Requisition ID 12014BR Job Category Quality Locations USA - Princeton, NJ Shift 1 Job Description Job Duties and Responsibilities: - Auditing - Act as a Lead Auditor - participate in audits, as assigned, according to applicable SOP(s) and the project Quality Plan - identify non-conformances with requirements and provide suitable recommendations - assure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management - ensure suitable responses and action plans provided by auditees - serve as a backup auditor to other QA&C staff . Special Projects - participate in QA projects - support special projects requiring QA input . Quality Assurance - contribute to process improvement initiatives across organization - develop and maintain global quality system to recognized standards - participate in development of QA processes and SOPs - support development of processes and SOPs by process owners outside QA . Liaison / Representation - represent QA on project teams, and other internal forums - represent QA at client meetings and/or audits Education/Qualifications Education / Qualifications Required . University/college degree (life science preferred) . Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process . Financial understanding of global clinical development budgets . Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs Preferred . BA/BS or equivalent experience . Knowledge of the drug development process from the perspective of a contract research organization Experience Required . Minimum of three (3) years experience in the pharmaceutical/CRO industries, with at least two (2) years in Clinical Quality Assurance, preferably within a GCP environment . Strong analytical skills . Knowledge, understanding and experience in applying ICH/FDA Good Clinical Practices . Excellent oral, written and presentation skills . Excellent planning and organizational skills . Proven interpersonal skills . Demonstrated ability to handle multiple competing priorities across clinical operating units . Ability to function as a member of a global clinical team
Please refer to Job code covance-154446 when responding to this ad.
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