Supplier Quality Specialist

Responsibilities Support and lead investigations related to deviations, Out of Specification (OOS) results, and nonconformance events. Identify, implement, and track corrective and preventive actions (CAPAs). Support Change Control activities for SOPs, test methods, specifications, and quality documentation. Utilize quality tools such as FMEA, Fishbone, 5 Why, risk analysis, and root cause methodologies during investigations and continuous improvement initiatives. Perform data analysis and trending activities to identify process improvements and quality risks. Support method validation, equipment qualification, and protocol execution activities. Maintain compliance with FDA, EU, ISO, cGMP, and other applicable regulatory standards. Assist during regulatory inspections, customer audits, and internal audit activities. Qualifications Bachelor’s degree in Life Sciences, Engineering, Chemistry, Biology, or related scientific discipline preferred. Minimum 3+ years of experience within pharmaceutical, biologics, medical device, or regulated manufacturing environments. Experience supporting Quality Systems including Deviations, CAPA, Change Control, Investigations, Auditing, and Document Control. Working knowledge of cGMP regulations, FDA requirements, ISO standards, and international regulatory expectations. Experience with supplier quality processes including qualification, auditing, supplier performance management, and risk assessments preferred. Familiarity with statistical analysis tools and data trending methodologies. Strong analytical, organizational, and problem-solving capabilities. Proficiency with Microsoft Office applications and electronic Quality Management Systems (eQMS). Excellent verbal and written communication skills with the ability to collaborate across multiple departments. #J-18808-Ljbffr