Posted in Manufacturing and Production
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 LLC
Job Description:
Company Summary:
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, agility and an interest in transformative action are also common attributes among our team.
Position Summary:
The QA Sr. Specialist will execute quality assurance related activities to ensure compliance with end to end operations (manufacturing, supply chain, QC, etc.), as well as monitoring of the Quality System Management health. 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 activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual's abilities to perform training, batch records review, data review to implement sound Quality System improvements, documentation review, deviation and CAPA management, change control, etc. In addition, the position requires someone with experience working on cross-functional settings. Client facing experience and data integrity remediation experience is a plus.
Position Responsibilities:
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