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Auditor II, QA |
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Job Category:
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Finance |
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Job description:
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We are currently searching for an Auditor II, QA for Austin, TX.
Successful candidate will be responsible for conducting routine audits (either according to internal requirements or as directed by a sponsor client), escorting sponsors or regulatory authorities during audits of facilities, resolving inspectional observations with management, and answering regulatory compliance questions. Responsibilities will include the following:
Schedule, plan and conduct audits as assigned by QA management
Generate accurate and timely written audit reports
Review written responses to observations to ensure that observations have been addressed
Maintain current knowledge of regulatory trends in areas of responsibility
All other projects as assigned
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Skills:
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Minimum of three years experience in the pharmaceutical, medical device, and/or biologic industry, with emphasis on clinical research, regulatory affairs and/or information technology/data management; Minimum of three years of auditing experience or related experience; Proficiency in a minimum of three of the following areas of QA auditing: GCP file audits, GCP pharmacy audits, GCP Investigator audits, GMP, GLP, departmental systems audits, computer validation, software life cycle development, electronic signatures and database audits preferred; Detail oriented and well organized; Excellent verbal and written communication skills; Ability to perform business travel, approximately 50%
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Bachelors |
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Experience (year):
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3 |
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Job Location:
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Austin - TX - USA |
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Post Date:
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11/17/2008 |
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