QC Specialist - Full time & Temporary

Asahi Kasei•Fremont, CA

11d•$48 - $60•Onsite

About The Position

Bionova is seeking a motivated and innovative QC Specialist to contribute to our expanding business. As part of the rapidly growing QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes. 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

BS in Biological Sciences or a related discipline.
Strong hands‑on experience with Bioassay, ELISA, qPCR, proper laboratory documentation, and safe laboratory practices; with proven experience in method validation, transfer, and regulatory compliance in a GMP environment.
Proficiency with SpectraMax and QuantStudio instruments.
Ability to follow and execute SOPs, protocols, and regulatory requirements.
Ability to interpret data and communicate results clearly.
Strong quality mindset, including knowledge of GDP, Data Integrity principles, and ALCOA+.
Knowledge of quality standards and global regulatory guidelines.
Experience with deviations, CAPA, change control, and related quality systems.
Demonstrated ability to work independently and collaboratively on cross‑functional teams, with strong analytical and logical problem‑solving skills.
Effective verbal and written communication skills.
Self‑motivated, organized, and able to manage multiple tasks in a fast‑paced environment.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

Nice To Haves

Preferred candidates have 5-7 years of experience with Bioassays and/or ELISA, and at least 3-5 years in a regulated QC GMP laboratory environment.

Responsibilities

Perform cell‑based assays, ELISA, and qPCR testing to support method qualification, in‑process testing, release, and stability studies while maintaining accurate GMP documentation.
Participate in the development, transfer, and validation of analytical and instrument‑based test methods (Bioassay, ELISA, qPCR).
Author and review technical documents, including method validation/qualification protocols and reports, as well as regulatory filing documents as required by project needs.
Complete, review, and maintain QC documentation, logbooks, and data records with accuracy and compliance.
Perform routine equipment maintenance in accordance with established procedures.
Prepare buffer solutions required for analytical procedures.
Manage inventory by monitoring stock levels and critical reagents, placing timely orders, and ensuring essential supplies remain available.
Support the development, revision, and adherence to SOPs, protocols, and quality documentation.
Independently troubleshoot and resolve issues related to analytical techniques and instrumentation.
Maintain adherence to GMP and quality standards.
Support regulatory inspections and contribute to observation responses.
Identify and implement process improvements to enhance efficiency and robustness of bioassay testing.