QO Secondary Packaging Tier I

Job description

Description Job Purpose: · Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations. · Ensures the accuracy and completeness of batch records. Performs other duties as assigned or apparent Essential Duties and Responsibilities: · Review Batch Records and applicable documentation to ensure complete, thorough and accurate data. · Responsible for ensuring a high level of employee accountability and performance. · Maintains quality assurance documentation including shift pass downs. · Keep QA work station clean and orderly. · Perform packaging line clearances. · Pull Retain, Stability, and Lab samples. · Perform or verify Quality Finished Product Attribute Inspections. · Perform AQL Calculations. · Verify component Exhibits · Verify all documents are present within the batch record. · Support validation and manufacturing studies, including special sampling and testing. · Communicate with Management any quality issues identified with product · Supplemental Functions: · Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. · Ass...