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Job Summary
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.
Responsible 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
Work Experience
2 years or more in Pharmaceutical QA -Required
Skills and Abilities
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
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity