(Contractor) Quality Assurance Engineer

Summary of Position

The (Contractor) Quality Assurance Engineer is responsible for supporting the Quality organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.

Work Schedule : Monday – Friday 8am – 5 : 00pm

Essential Functions

• Identify and implement Corrective Actions Investigate Exceptions (Deviations).
• Generate or review Change Controls for Batch Records, Standard Operating Procedures, Standard Test Methods, Specifications, Data Sheets, etc.
• Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.
• Perform analysis of data in support of investigations, cost savings, continuous improvement initiatives Work with radioactive materials.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety / Quality guidelines and SOP’s.
• Maintain current knowledge of US and international quality regulations
• Author or perform peer review of annual product quality reviews.
• Provide support for regulatory agency (i.e. FDA, HC, TGA, EU, etc.) on-site audits, as required.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).

Requirements

Working Conditions :