QC Specialist - EM and Micro Testing

Asahi Kasei•Fremont, CA

18h•$80,000 - $100,000•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. 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 and an interest in transformative action are also common attributes among our team. Position Summary: The QC Lab at Bionova is seeking a self-motivated, innovative, and team-oriented QC Analyst with strong technical and communication skills to support microbiology testing of biologics. In this role, you will contribute to a dynamic and expanding business as part of a rapidly growing Quality Control team. You will have the opportunity to influence decisions, collaborate cross-functionally, and develop your own skills while working toward project goals that ultimately improve patient outcomes.

Requirements

Bachelor's Degree or above from an accredited institution in Microbiology, Biology (or closely related degree).
Requires 4+ years of quality pharmaceutical, bio-pharmaceutical, or combi-medical device experience, and analytical testing experience on Biologics.
An energetic scientist and a creative thinker who can explore and identify better and more efficient methods to address issues and gaps.
Demonstrate ability to work independently and on cross-functional teams.
Strong attention to detail and following procedures and requirements.
Effective verbal and written communication skills.
Great interpersonal and teamwork skills.
At least 2 years of Technical Writing skills such as SOP, CAPA, deviation reports etc.

Responsibilities

Perform microbiology testing for routine EM, release, stability, and method verification samples.
Read plates from environmental monitoring and media fill.
Perform growth promotion, and Gram Staining.
Perform endotoxin, TOC, and bioburden testing.
Enter data in electronic systems and LIMS.
Manage and orders supplies as needed for testing.
Assist in QC team implementation of GMP procedures, processes, and systems.
Train QC staff on instrumentation, techniques, microbiology methods.
Initiate trend reports.
Author/review/approve technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents per project needs.
Initiate/Investigate deviations, Change control and CAPA.
Maintain lab equipment as appropriate per procedures.
Contribute to investigation of issues and non-conformities to products and projects and perform troubleshoot of equipment and testing procedures to identify root causes of issues and participate in lab investigations.
Help in maintaining the QC lab in a clean, organized and compliance at all times.
Perform other QC tasks as required.