QA Specialist Temporary

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.

Bionova Scientific LLC

The QA Specialist will provide Quality Assurance for Quality Control and Analytical Laboratories. Working in a fast‑paced CDMO environment with a broad scope of responsibilities, the candidate will be able to bring many different skills to the job, with a focus on QA expectations for QC activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual’s abilities to perform investigations, self‑inspection audits, and analytical data review to maintain and expand Quality Control capabilities.

In addition, the position requires someone with strong document management and change control experience in procedures used in GMP environment.

Location:

Fremont, California

Bionova B1 building 3100 W. Warren Ave, Fremont, CA 94538

• Perform batch related records review
• Perform QA release of raw materials in QAD ERP System.
• Evaluate compliance of completed manufacturing records (sample plans, sample submission forms, etc.) and quality control records (test/analytical results)
• Evaluate document changes for compliance requirements (SOPs, Master Batch Records, specifications, test methods, etc.)
• Review all the supporting documents regarding Quality Control documentation including deviations (such as OOS), CAPAs, and change controls
• Collaborate with Manufacturing, Quality Control, and Analytical Development to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations
• Support cGMP compliance audits of GMP suppliers’ quality systems
• Support Document Control related processes
• Support and conduct training for employees, as necessary
• Perform other related duties as assigned from time to time based on company needs

• This position required to 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 40 pounds independently.

• Bachelor’s or higher degree in sciences
• 2-4 years of combined manufacturing process development, manufacturing, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries
• 2-4 years experience in a GMP environment
• Experience in manufacturing of drug substances or drug products is a plus
• Knowledge of GMP regulations and guidance (such as US, EU, and ICH)
• Experience with Quality Assurance systems and processes
• Effective organization and planning skills
• Demonstrated ability to deal with frequent changes, delays, or unexpected events
• Strong technical writing skills
• Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro, and Master Control (a plus)) and demonstrated troubleshooting and problem‑solving techniques
• Ability to work under tight deadlines and pressure in a composed manner
• Effective interpersonal and communication skills
• Strong…