Supplier Quality Specialist — Audits, CAPA & Continuous Improvement

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, vision and dental

Health savings account (HSA)

Holiday/paid time off

Job summary

Fagron Sterile Services US in Wichita, KS is seeking a Supplier Quality Specialist to ensure suppliers meet quality standards and regulatory requirements. You'll collaborate with procurement, manufacturing, engineering, and quality teams to drive continuous improvement and resolve quality issues.

The role involves supplier audits, CAPA review, data analysis, and documentation, helping to reduce defects and costs while ensuring compliance with industry standards.

Qualifications

• High School Diploma and preferred cGMP experience in a pharmaceutical manufacturing environment.
• Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
• Proficient in MS Office programs, including Word and Excel.
• Ability to process information rapidly from multiple sources and communication channels.
• Ability to handle a high volume of work and rapidly adapt to changing environment.

Responsibilities

• Evaluate and qualify new suppliers through audits, assessments, and performance reviews.
• Monitor supplier quality performance using key metrics reported.
• Investigate supplier-related quality issues and lead root cause analysis activities.
• Review and approve supplier CAPA and SCAR actions.
• Collaborate with purchasing and engineering during supplier development.
• Analyze quality data and prepare reports on supplier performance trends.
• Ensure compliance with standards, regulations, and customer requirements.
• Support new product introductions by validating supplier processes.
• Drive continuous improvement to reduce defects and costs.
• Maintain supplier quality documentation and audit reports.
• Participate in audits with NA teams for QMS and standards.

Skills

Quality systems

cGMP familiarity

Communication skills

Education

High School Diploma

Tools

MS Office (Word/Excel)

Job description

Fagron Sterile Services US in Wichita, KS is seeking a Supplier Quality Specialist to ensure suppliers meet quality standards and regulatory requirements. You'll collaborate with procurement, manufacturing, engineering, and quality teams to drive continuous improvement and resolve quality issues.

The role involves supplier audits, CAPA review, data analysis, and documentation, helping to reduce defects and costs while ensuring compliance with industry standards.