Quality Assurance Specialist - Supplier Quality

Bionova Scientific LLC; Fremont (CA); On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

Health benefits

401K match

Paid time off

Holidays

Sick leave

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a GMP Quality Assurance Compliance professional to lead supplier qualification, self-inspection and client/audit readiness initiatives.

The role requires 5+ years in GMP QA, strong data analysis, and experience with ERP/eQMS; excellent communication and documentation skills are essential. Collaborative environment with growth opportunities and competitive benefits.

Qualifications

• Bachelor of Science in a scientific field.
• Minimum 5 years' GMP QA and quality systems experience.
• Experience with ERP and eQMS systems required.
• Strong data analysis and trend analysis skills.
• Knowledge of GMP regulations (21 CFR 210/211/11, ANNEX 1, ICH).
• Excellent written and verbal communication.

Responsibilities

• Assess suppliers' quality systems and processes to meet standards.
• Interface with suppliers/clients to obtain documentation and draft quality agreements.
• Negotiate and maintain quality agreements with suppliers.
• Perform change control, discrepancy management, and supplier investigations.
• Conduct on-site supplier audits to verify GMP compliance.
• Identify quality risks and implement mitigation strategies.
• Coordinate inspection readiness and support audits.
• Prepare metrics and report to senior management.
• Support regulatory, client audits and self-inspections.

Skills

GMP QA

Quality Systems

Data analysis

Documentation

Excellent communication

Education

Bachelor of Science in science

Tools

ERP systems

eQMS

QA software

Job description

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.Company:Bionova Scientific LLCJob Description:

Position Summary

This role 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 BNS supplier qualification program. The role also supports Bionova Scientific's self-inspection program, as well as management of the client audits and health authority inspections. 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.

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
• 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 to senior management 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 5 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

Compensation Range

The base compensation range for this role is between $95,000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program

Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks10 days of Holidays and 5 days of Sick Leave.

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.