Quality Operations 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. - As...