Senior Supplier Quality Assurance Specialist

incog; Fishers (IN); On-site; USD 95,000 - 130,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a QA Senior Specialist - Supplier Quality to lead supplier qualification, oversight and change notifications, ensuring GMP-compliant materials for parenteral injectables.

You will partner with Purchasing and QA Operations, coordinate supplier audits, maintain qualification files, and drive continuous improvement across the supply chain in a fast-paced GMP environment.

Qualifications

• Bachelor's degree and minimum 3 years' experience in supplier quality in pharma or medical devices.
• Experience with supplier auditing or audit coordination.
• Strong knowledge of GMP regulations and ICH guidelines.
• Excellent written and verbal communication with cross-functional teams.

Responsibilities

• Lead the qualification and approval process for new suppliers and evaluate quality systems.
• Maintain supplier qualification files and approved supplier lists.
• Collaborate with Purchasing to ensure only approved materials are procured.
• Write and revise SOPs governing the Supplier QA system.
• Review and process Supplier Change Notifications and coordinate reviews.
• Perform risk-based evaluation of suppliers and issues.

Skills

Supplier quality management

GMP knowledge

FDA regulations

Auditing

Education

Bachelor's degree in life sciences

Tools

QMS software

Document management systems

Job description

INCOG BioPharma Services in Fishers, IN is seeking a QA Senior Specialist - Supplier Quality to lead supplier qualification, oversight and change notifications, ensuring GMP-compliant materials for parenteral injectables.

You will partner with Purchasing and QA Operations, coordinate supplier audits, maintain qualification files, and drive continuous improvement across the supply chain in a fast-paced GMP environment.