QC Specialist - Full time & Temporary

Bionova Scientific, Inc.; Fremont (CA); Vor Ort; USD 66.124 - 82.656; Vollzeit

Zusammenfassung

Bionova Scientific LLC in Fremont, CA is seeking a motivated QC Specialist to join our growing biologics CDMO. In this role you will perform cell-based assays, ELISA, and qPCR to support method validation and in-process testing, ensuring accurate GMP documentation and data integrity.

The position is full-time, on-site in Fremont, with responsibilities spanning method transfer, instrument validation, and routine QA activities.

Qualifikationen

• BS in Biological Sciences or related discipline with GMP lab experience.
• 5–7 years in Bioassays/ELISA with regulatory QC exposure preferred.
• Proven skills in data integrity, documentation, and regulatory compliance.

Aufgaben

• Perform cell-based assays, ELISA, and qPCR supporting testing and stability studies.
• Develop, transfer, and validate analytical methods and instrument integration.
• Prepare and maintain GMP documentation and regulatory filings as needed.
• Troubleshoot analytical instruments and maintain quality systems adherence.
• Support SOPs, CAPA, deviations, and change controls; enable efficient QC operations.

Kenntnisse

Bioassay

ELISA

qPCR

SOPs

GMP

Data Integrity

SpectraMax

QuantStudio

CAPA

Change Control

Ausbildung

BS in Biological Sciences

Tools

SpectraMax

QuantStudio

Jobbeschreibung

## QC Specialist - Full time & TemporaryApplyremote type: On-sitelocations: Fremont, CAtime type: Full timeposted on: Posted 2 Days Agojob requisition id: R5693## 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+.* 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).The base compensation range for this role is $48 to $60 an hour. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.