QA Auditing Reviewer

QA Auditing ReviewerThis QA Auditing Reviewer role is responsible for thoroughly auditing production records, determining batch disposition (Release, Hold, Reject), and executing those decisions in systems like JDE while ensuring held or rejected batches are properly controlled and stored. It also logs and loads batch data into required databases, regularly audits QA in-process data, and may fill in for in-process QA inspectors when needed.Essential FunctionsThoroughly 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 in accordance with established QA ProcessesLoad batch data into the APR database (if required)Communicating clearly and concisely, both orally and in writing.Operating scientific calculators and personal computersPerforms timely reviews of QA In-Process DataAdditional ResponsibilitiesMust be able to fill in for In-process QA inspectors when circumstances dictateQualificationsEducation:High School or GED - RequiredBachelors Degree in Related Field - PreferredExperience:2 years or more in Pharmaceutical QA, QC or QMSpecialized Knowledge:Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packagingComprehensive understanding of GMP standards, including 21 CFR Parts 210, 211, 820, and relevant ICH guidance.Required SkillsCalibrationData EntryDetail OrientedFacility InspectionFirst Article InspectionsGood Manufacturing PracticesInvestigationLaboratory Information Management SystemsQuality Management SystemsUnited States Pharmacopeia (USP) ComplianceVisual InspectionsAbout UsAmneal is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at Requests will be handled confidentially and in accordance with applicable laws.Job InfoJob Identification 8410Job Category Quality AssuranceLocations 49 Colonial Drive, Piscataway, NJ, 08854, USJob Schedule Full time