Sr. QA Specialist, Supplier Quality

Bionova Scientific LLC; United States; Hybrid; USD 120,000 - 150,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a Sr. QA Specialist, Supplier Quality to strengthen the QA Compliance team. You will assess suppliers' quality systems, lead supplier audits, and support client and regulatory inspections in a hybrid, lab/office setting.

The role requires 10+ years GMP QA experience, ERP/eQMS proficiency, strong data analysis, and excellent communication. Base pay ranges from $120k to $150k yearly.

Qualifications

• Minimum 10 years GMP QA and Quality Systems experience.
• Experience with ERP and eQMS systems is required.
• Strong data and trend analysis skills.
• Excellent written and verbal communication.

Responsibilities

• Assess supplier quality systems and capabilities to meet standards.
• Interface with suppliers/clients to request documents and establish quality agreements.
• Negotiate and maintain quality agreements with suppliers.
• Lead on-site supplier audits for GMP compliance.
• Identify quality risks and implement mitigation strategies.
• Coordinate inspection readiness and support regulatory/client audits.
• Prepare metrics for management reviews and communicate dispositions.

Skills

GMP Quality Assurance

Supplier Quality

Data analysis

Written & verbal communication

Regulatory knowledge (21 CFR 210/211//

Education

Bachelor's degree in science or equivalent

Tools

ERP systems

eQMS systems

Quality management software

Job description

Company

Bionova Scientific LLC

Job Description

This Sr. QA Specialist, Supplier Quality is part of the Quality Assurance Compliance team. As a member of the QA team, the role incumbent has GMP Quality experience assessing supplier’s compliance and managing the Bionova Scientific’s (BNS) supplier qualification program. The role also supports Bionova Scientific’s self-inspection program, as well as management of the client audits, health authority inspections, and quality management review.

The position requires a high attention to detail, to be organized in their work, strong written and verbal communication skills and working well independently and in a team environment.

Location

Fremont, CA

Hybrid – 3-4 days in office a week

Position 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

Working Conditions

This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 15 pounds independently.

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
• Excellent written and verbal communication skills to effectively document findings and present technical information
• 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
• Effective interpersonal and communication skills.
• Communication at all management levels and all staff is required
• Proficiency with relevant quality management systems and software

Base Compensation Range

The base compensation range for this role is $120,000-$150,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Equal Opportunity Statement

#LI-MG1 #Hybrid As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.