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Beacon Hill Life Sciences is looking for a Quality Assurance Engineer to conduct investigations, handle change management, identify and implement continuous improvement opportunities, and maintain 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 Whys, Risk Analysis, HFAT, etc.) in support investigations and special projects.
- Perform analysis of data in support of investigations, cost savings, and continuous improvement initiatives. Work with radioactive materials.
- Ensure a safe, high-quality working environment through training, awareness, and compliance with safety/Quality guidelines and SOPs.
- Maintain current knowledge of US and international quality regulations
- Author or perform peer review of annual product quality reviews.
- Provide support for regulatory agency on-site audits (e.g., FDA, HC, TGA, EU, etc.), 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 place of a 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 the use of Microsoft Office suite products.
- Good computer skills, including utilizing personal computers and data entry programs.
- Good hands-on, analytical, problem-solving, and decision-making skills.
- Excellent writing and verbal communication skills.
- Ability to work independently and with others to accomplish goals and priorities.
- High energy level and regular, consistent attendance.
AJNJN1431595_1765229717