Senior QA Specialist, Supplier Quality & Compliance

Pharmaceutical Compliance Forum Inc; Fremont, Northern (CA, KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Bionova Scientific LLC, a биologics CDMO, seeks a Sr. QA Specialist in Fremont, CA for supplier quality oversight. The role includes reviewing supplier quality systems, conducting on-site audits, and managing supplier documentation and quality agreements.

The position requires a Bachelor of Science in a scientific field and at least 10 years in GMP QA/QMS, with strong data analysis and communication skills to interact with suppliers and internal teams.

Qualifications

• Bachelor of Science degree in a scientific field is required or equivalent.
• Minimum 10 years GMP Quality Assurance and Quality Systems experience.
• Experience with ERP and eQMS systems is a must.

Responsibilities

• Assess potential suppliers through thorough reviews of quality systems and capabilities.
• Interface with suppliers/clients to obtain materials, establish quality agreements.
• Negotiate and maintain quality agreements with suppliers and QA teams.
• Lead on-site supplier audits to verify GMP compliance and procedures.
• Coordinate corrective actions for supplier-related quality issues and prepare metrics.

Skills

GMP Quality Assurance

Quality Systems

Supplier Quality

Data analysis

Excellent communication

Education

Bachelor of Science in a scientific field

Tools

ERP systems

eQMS systems

Job description

Bionova Scientific LLC, a биologics CDMO, seeks a Sr. QA Specialist in Fremont, CA for supplier quality oversight. The role includes reviewing supplier quality systems, conducting on-site audits, and managing supplier documentation and quality agreements.

The position requires a Bachelor of Science in a scientific field and at least 10 years in GMP QA/QMS, with strong data analysis and communication skills to interact with suppliers and internal teams.