New
Quality Specialist
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![]() United States, Pennsylvania, West Point | |
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Quality Specialist 23 months West Point, PA 19486 * Hybrid Role@WestPoint,PA(3 days onsite) Qualifications: Education: * Bachelor's Degree or higher in engineering, science, or related discipline. Required skills and experience: * Minimum 2 years of experience in the pharmaceutical or equivalent industry, Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations. * Familiarity with batch disposition activities * Strong problem-solving, and written and oral communication skills * Ability to manage multiple priorities * Demonstrated teamwork skills and ability to work independently * Proficiency in the use and maintenance of Microsoft applications (Excel, Outlook, and/or MS Access, Teams) * Attention to detail, flexibility and an awareness of production and quality control problems. Preferred skills and experience: * Proven ability to work independently and collaborate effectively as part of a team. * Strong organizational, interactive, and time management skills. * Computer skills; knowledge and competency in ERP/MES, SAP Responsibilities: Our department supports the release of clinical supply to global clinical trials. Primary duties may include but are not limited to the following: * Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations. * Coordinate and/or support the preparation of procedures, processes and quality improvements. * Completing projects to improve the performance of our processes, including continuous process improvements, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times. * Assists in the coordination of significant quality events including fact finding, investigation support * Actively using and championing the use of Lean Six Sigma and our company's Production System (MPS) tools, both in problem solving and day-to-day operational activities. |