Supplier Quality Specialist

Supplier Quality Specialist at Harba Solutions Inc. Supplier Quality Specialist at Harba Solutions Inc. in Noblesville, Indiana Posted in 8 days ago.

Type:

full-time

Job Description:

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