Quality Assurance Auditor II

The Quality Assurance Auditor II performs quality-critical activities to ensure our finished products and raw materials meet Colorcon’s quality standards and the requirements of our customers, while meeting Colorcon’s regulatory and certification commitments. This position requires the ability to work independently, take ownership of decisions, and contribute to continuous improvement of quality systems and processes. This role directly reports to the Quality Assurance Supervisor. Primary Responsibilities Duties Verify that finished products (wet, dry, lake, PVAP) are manufactured and tested in accordance with approved specifications. Manage lake and PVAP batch release processes (label generation, closing/approving lots, batch creation, etc.) Approve or reject intermediates and finished goods in accordance with approved specifications. Verify raw materials and packaging materials are tested in accordance with approved specifications; conduct focused quality reviews of raw material and packaging testing records to verify information from the suppliers’ COA and the work performed by Colorcon Quality Control Scientists. Conduct and document supplier and internal non-conformance investigations in CSS, including root cause analysis and support for corrective and preventive actions (CAPAs), as required. Conduct real-time auditing of manufacturing activities and focused quality reviews of production records to ensure compliance with SOPs and cGMP. Support manufacturing in identifying and resolving quality-related issues. Actively support plant and laboratory activities in their respective areas. Contribute to the continuous improvement of quality processes and systems. Actively promote GMP awareness at all levels within the company. Daily/weekly QA representative for all production relevant meetings. Manage electronic storage of batch manufacturing records and other quality related records. Other quality-related activities as required to support site operations and quality objectives.