Senior 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 teams

Qualifications:

• 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