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.