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qa auditor i

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Amneal Pharmceutical of New York LLC

Brookhaven, NY

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Description: * Thoroughly audit all production records (work order #1 and #2 for commercial and exhibit batches) and determine batch disposition (Release, Hold, Reject) Essential Functions: * Thoroughly audit all production records (work order #1 and #2 for commercial and exhibit batches) and determine batch disposition (Release, Hold, Reject). Physically perform batch disposition for each lot of product produced, including making the correct entries in JDE. * Resposible for making sure Batches placed on Hold or Reject status are appropriately stored in their designated limited access areas. * Log RFT data as required by Management * Load batch data into the APR database (if required) * Communicating clearly and concisely, both orally and in writing. * Operating scientific calculators and personal computers * Audit QA in-process data regularly and timely Additional Responsibilities: * Must be able to fill in for In-process QA inspectors when circumstances dictate Education: * High School or GED - Required Experience: * Pharmaceutical QA Skills: * Excellent organizational skills with proficiency in computers. - Beginner * Ability to produce sufficient work within a stipulated time frame. - Beginner * High energy level and organizational skills. - Beginner * No unusual physical or mental demands or work conditions - Beginner Specialized Knowledge: * Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packaging * Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guidelines Licenses:

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Amneal Pharmceutical of New York LLC

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QA Auditor I
location Brookhaven, NY
Job Views : 1 Location: Brookhaven, New York, , United States Job Category: Accounting Employment Type: Full time Salary: Job Description Description: * Thoroughly audit all production records (work order #1 and #2 for commercial...
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