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QC Specialist - Full time & Temporary

Bionique Testing Laboratories LLC

Fremont, California

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JOB DETAILS
SALARY
$48–$60 Per Hour
SKILLS
Analysis Skills, Assays, Biological Assay, Biology, Business Growth, Cell Cultures, Communication Skills, Computer Networks, Customer Relations, Data Quality, Documentation, Equipment Maintenance/Repair, GMP (Good Manufacturing Practices), Healthcare, Identify Issues, Instrumentation, Inventory Management, Laboratory Techniques, Maintain Compliance, Manufacturing, Patient Care, Problem Solving Skills, Procedure Development, Process Improvement, Quality Assurance Methodology, Quality Control, Quality Metrics, Real-time PCR (qPCR), Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Resolve Customer Issues, Standard Operating Procedures (SOP), Talent Management, Technical Writing, Testing, Time Management, Validation Plan, Writing Skills
LOCATION
Fremont, California
POSTED
13 days ago
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:

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.

Location: Fremont, California

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

Temporary role - Full Time

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.

Essential Duties and 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.

Working Conditions:
  • 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 20 pounds independently.

Qualifications:
  • BS in Biological Sciences or a related discipline. 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.
  • 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+.
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About the Company

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Bionique Testing Laboratories LLC