Supplier Quality Specialist

Key Responsibilities:• Lead and support investigations related to deviations, non-conformances, and out-of-specification results• Identify root causes and implement corrective and preventive actions (CAPAs)• Support change controls, SOP revisions, and document management activities• Utilize quality tools such as Fishbone, FMEA, 5 Why, and risk analysis methods• Assist with method validations, equipment qualifications, and continuous improvement projects• Analyze data and trends to support quality and operational improvements• Ensure compliance with cGMP regulations and internal quality standards• Support internal and external audits as needed• Collaborate cross-functionally with Quality, Manufacturing, Engineering, and Operations teamsQualifications:• Bachelor’s degree in Life Sciences, Engineering, or related field• 3+ years of experience in pharmaceutical, biotech, or medical device manufacturing environments• Strong understanding of quality systems including deviations, CAPAs, change controls, investigations, and document control• Knowledge of cGMP regulations and regulated manufacturing operations• Experience using root cause analysis and quality tools• Strong analytical, communication, and problem-solving skills• Proficiency with Microsoft Office and data analysis tools