Senior QA Specialist, Supplier Quality & Compliance

Asahi-Kasei; Fremont (CA); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a Senior QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. The role focuses on GMP quality, supplier qualification, and supporting client and health authority inspections in a hybrid office/lab setting.

You will assess supplier quality systems, manage change controls and investigations, and lead on-site supplier audits to ensure compliance with GMP standards. Strong communication and data analysis skills are essential.

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.
• Excellent written and verbal communication skills to document findings.
• Working knowledge of GMP regulations and guidance (21 CFR 210/211/11, ANNEX 1, ICH, etc.)
• Effective organization and planning skills.
• Demonstrated ability to deal with frequent changes, delays, or unexpected events.

Responsibilities

• Assessing potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet required quality standards.
• Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements as applicable, etc…
• 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 compliance with established Bionova quality requirements, GMP practices, and documented procedures
• Identifying potential quality risks associated with suppliers and implementing mitigation strategies to minimize risks to product quality
• Maintaining open communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvement
• Enforce quality assurance policies and procedures to maintain product quality and compliance
• Investigating and managing discrepancies that may impact product quality, ensuring proper documentation and corrective actions are taken
• Compile metrics for presentation for quality management review and communicate disposition status in a timely manner
• Coordinate the inspection readiness program for Bionova Scientific
• Preparing for and supporting regulatory agency audits, client audits and self-inspection

Skills

GMP Quality Assurance

Data analysis

Trend analysis

Regulatory knowledge

Communication skills

GMP regulations

Education

Bachelor of Science or equivalent in a scientific field

Tools

ERP systems

eQMS systems

Job description

Bionova Scientific LLC in Fremont, CA is seeking a Senior QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. The role focuses on GMP quality, supplier qualification, and supporting client and health authority inspections in a hybrid office/lab setting.

You will assess supplier quality systems, manage change controls and investigations, and lead on-site supplier audits to ensure compliance with GMP standards. Strong communication and data analysis skills are essential.