Quality Specialist - I (Assistant)

Job Title Quality Specialist – I Location & Working Arrangement WestPoint, PA (Hybrid – 3 days onsite per week; Tuesday & Wednesday mandatory, the third day flexible between Monday or Thursday). Expected start around July 27, initially 1 year with option to extend up to 2 years. Working 8 hours per day, 40 hours per week, no overtime, no travel. Job Overview The role involves reviewing clinical finished goods batch records, performing batch disposition, conducting label reviews, and supporting batch/product review activities. Focus on ensuring compliance with GMP, policies, and regulations. Responsibilities Evaluate and disposition clinical supply materials ensuring they were produced in conformance with all applicable policies, procedures, and governing regulations. Coordinate and support preparation of procedures, processes, and quality improvements. Complete projects to improve process performance, including continuous process improvements and value capture projects that seek to improve yield, reduce cost, or lower cycle times. Assist in coordination of significant quality events including fact-finding and investigation support. Actively use and champion Lean Six Sigma and the company's Production System (MPS) tools in problem solving and day-to-day operational activities. Qualifications & Requirements Bachelor's Degree or higher in engineering, science, or related discipline. Minimum 2 years of experience in the pharmaceutical or equivalent industry, GMP related field including Technical, Engineering, Quality or Operations. Familiarity with batch disposition activities. Strong problem‑solving, written, and oral communication skills. Ability to manage multiple priorities. Demonstrated teamwork skills and ability to work independently. Proficiency in Microsoft applications (Excel, Outlook, MS Access, Teams). Attention to detail, flexibility, and an awareness of production and quality control problems. Preferred: 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, SAP, MEDS, VEEVA. #J-18808-Ljbffr TALENT Software Services