QA Auditor II at Amneal Pharmceutical of New York LLC

Posted in Manufacturing 10 days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Brookhaven, New York

Job Description:

Description:


  • To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To ensure quality compliance before, during and after each manufacturing and packaging run. To review PBR for work order# 1 (manufacturing) and work order# 2 (packaging) and determine batch disposition.

Essential Functions:


  • All requirements of QA Auditor I, plus the following:

  • Maintain log books for Planned Deviations, Reject Reports, and Finished Product COA. Issuing Planned Deviation numbers and Manage Planned Deviations from requests through closure.

  • Analyzing RFT Data and provide trending reports to QA/OPS Supervisors and Managers.

  • Manage Annual Stability Check Lot Program

  • Manage NOI Batches in JDE

Additional Responsibilities:


  • Must be able to fill in for In-process QA inspectors when circumstances dictate.

Education:


  • High School or GED - Required
Experience:


  • QA or related field
Skills:


  • Good basic math knowledge and excellent attention to details - Intermediate

  • Excellent organizational skills with proficiency in MS Word, Excel, and Powerpoint - Intermediate

  • Ability to produce sufficient work within the stipulated time - Intermediate

  • High energy level and organizational skills - Intermediate

  • Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packaging - Intermediate
Specialized Knowledge:


  • Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guidelines
Licenses: