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Basic Function and Responsibility:
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Responsible for assuring the quality of laboratory and technical data. . |
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The objective of the QA/QC Review Process is to evaluate chromatographic data to assure
compliance with analytical methods, FDA's Good Manufacturing Practices in the QA/QC Laboratory, and current Good Manufacturing
Practices. |
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The batch release function relies on a thorough technical review of analytical and technical
batch-related documentation. |
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Knowledge, Skills, and Abilities:
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Knowledge of chromatography, analytical methodology, and FDA regulations. |
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3 years of QA/QC experience; equivalent lab experience preferred. |
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Excellent verbal and written communication skills. |
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Detail oriented and able to set priorities. |
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Education and Experience:
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Bachelor's degree in Chemistry or related science.
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3-5 years of pharmaceutical experience, 3 years in the laboratory, or reviewing lab data.
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Thorough knowledge of laboratory processes, FDA regulations.
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How To
Apply |
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