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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.
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
- Bachelor of Science in Biology, Chemistry or related field required. Work experience is considered in lieu of degree.
- 3 or more years of relevant experience required.
- Must be able to resolve problems, handle conflict and make effective decisions under pressure.
- Ability to do simple to complex math calculations, input data into the computer and analyze data as required.
- Must be proficient in use of Microsoft suite office products.
- Good computer skills, including utilizing personal computers and data entry programs.
- Good hands on, analytical, and problem solving and decision-making skills.
- Excellent writing and verbal communications skills.
- Ability to work independently and with others to accomplish goals and priorities.
- High level of energy and regular, consistent attendance.
