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.
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
Must be able to fill in for In-process QA inspectors when circumstances dictate.
High School or GED - Required
QA or related field
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
Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guidelines