Senior QA Specialist, Supplier Quality (GMP)

Bionova Scientific, Inc.; Fremont, Northern (CA, KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Bionova Scientific LLC in Fremont, California, is seeking a Sr. QA Specialist, Supplier Quality, to strengthen our supplier qualification program and support self-inspections, client audits, and health authority inspections.

The role requires a disciplined, detail-oriented professional with GMP knowledge, strong communication, and the ability to work independently and with teams to maintain product quality and regulatory compliance.

Qualifications

• Bachelor of Science degree or equivalent in a scientific field.
• Minimum of 10 years GMP Quality Assurance and Quality Systems experience.
• Experience with ERP and eQMS systems.
• Strong data analysis and trend analysis capabilities.

Responsibilities

• Assess supplier quality systems, processes, and capabilities against standards.
• Interface with suppliers and clients to obtain material documentation and quality agreements.
• Negotiate and maintain quality agreements outlining product specs and QC procedures.
• Lead on-site supplier audits and report findings per procedures.
• Identify quality risks and implement mitigation to protect product quality.
• Coordinate inspection readiness and support regulatory and client audits.

Skills

GMP QA

Quality Systems

Data analysis

Verbal/written communication

Auditing

Education

Bachelor of Science in a scientific field

Tools

ERP systems

eQMS systems

Job description

Bionova Scientific LLC in Fremont, California, is seeking a Sr. QA Specialist, Supplier Quality, to strengthen our supplier qualification program and support self-inspections, client audits, and health authority inspections.

The role requires a disciplined, detail-oriented professional with GMP knowledge, strong communication, and the ability to work independently and with teams to maintain product quality and regulatory compliance.