Hybrid Senior QA Specialist - Supplier Quality & Compliance

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

Job summary

Bionova Scientific LLC, Fremont, CA, is seeking a Sr. QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. You will assess supplier quality systems, manage supplier qualification, support self-inspections, and coordinate client and health authority inspections.

The role requires extensive GMP QA experience, with strong written and verbal communication, detail orientation, and ability to work independently and in a team. Hybrid schedule with 3–4 days in-office.

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 systems and eQMS systems is a must.
• Expertise in data analysis, trend analysis.
• Strong understanding of pharmaceutical manufacturing processes and documentation requirement.

Responsibilities

• Assessing supplier quality systems, manufacturing processes, and capabilities to ensure they meet quality standards.
• Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements.
• Negotiating and maintaining quality agreements with suppliers, outlining expectations regarding product specifications, quality control procedures, and reporting requirements.
• Perform actions associated with Change Control documents, discrepancy management and supplier investigations.
• Leading and conducting regular on-site audits at supplier facilities to verify GMP compliance.
• Identifying potential quality risks associated with suppliers and implementing mitigation strategies.

Skills

GMP quality

Data analysis

Trend analysis

Document control

Quality systems

Communication

GMP regulations

Education

Bachelor of Science degree

Tools

ERP systems

eQMS systems

Job description

Bionova Scientific LLC, Fremont, CA, is seeking a Sr. QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. You will assess supplier quality systems, manage supplier qualification, support self-inspections, and coordinate client and health authority inspections.

The role requires extensive GMP QA experience, with strong written and verbal communication, detail orientation, and ability to work independently and in a team. Hybrid schedule with 3–4 days in-office.