Quality Assurance Specialist - Supplier Quality

Asahi Kasei•Fremont, CA

2d•Onsite

About The Position

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.

Requirements

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

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