Reagent QA Associate I

At Cytek Biosciences, our mission is to enable the world to improve life through scientific innovation. We are committed to delivering powerful solutions that allow scientists to rapidly and efficiently obtain deep biological insights through high-quality, highly parametric datasets.

Our commitment to quality is foundational. In 2023, Cytek earned ISO 13485:2016 certification at our Fremont headquarters, covering the design, development, manufacturing, distribution, installation, and servicing of our innovative flow cytometers, reagents, and accessories. Our Wuxi (China) and San Diego reagent manufacturing facilities have also obtained this globally recognized quality standard.

The Quality Assurance & Regulatory Affairs (QA/RA) Department is at the heart of this excellence. The team ensures that every reagent and system we deliver meets both rigorous internal benchmarks and external regulatory expectations-embodying our "qualityfirst" mindset across manufacturing, audits, compliance, and documentation.

As a QA Associate I, you'll be the driving force behind our reagent products-ensuring they're manufactured, tested, and released according to company quality standards and regulatory requirements (e.g., cGMP, ISO 13485, FDA). You'll play a key role in sustaining our commitment to excellence across documentation, product release, inspections, nonconformance investigations, quality system upkeep, and more.

• Be a quality champion: Actively promote and sustain a culture of quality through training, daily guidance, and collaboration across teams.

• Drive real outcomes: Your precise reviews of production records and certificates of analysis ensure only fully compliant products reach our customers.

• Solve challenges creatively: Whether investigating nonconformances or managing quarantine workflows, you'll bring clarity and efficiency to essential quality processes.

• Shape quality systems: Contribute to audits, regulatory inspections, SOP updates, work instructions, and equipment calibration activities.

• Review and release production records and certificate of analysis promptly.

• Inspect incoming raw materials, coordinate QC testing, and manage inventory-including handling nonconformances.

• Facilitate containment, quarantine, and scrap processes for nonconforming products.

• Maintain robust documentation systems-filing, scanning, and updating records, SOPs, and calibration logs.

• Ensure full compliance with cGMP and ISO 13485 in all processes.

• Conduct audits and assist with regulatory inspections.

• Collaborate cross-functionally across manufacturing, supply chain, and operations.

• Identify and drive continuous improvement opportunities.

• Bachelor's degree in Chemistry, Biochemistry, or a related field.

• 0-3 years of experience in Reagent QC or Quality Assurance within life sciences.

• Familiarity with Quality Management Systems (e.g., Propel), SOP development, and audit processes.

• Strong written and oral communication skills, multitasking ability, and a collaborative mindset.

• Bonus points for experience in regulated lab environments (GLP/cGMP) or direct exposure to ISO 13485 and FDA QSR requirements.

• You'll help uphold and elevate product quality and compliance-impacting both internal excellence and external regulatory alignment.

• Enjoy a collaborative environment where QA/RA isn't siloed-you'll work closely with multifunctional teams across the organization.

• This role offers meaningful professional growth opportunities, positioning you for future leadership, systems, or compliance-focused roles.

Cytek is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.