Sr. Document Control & Training Specialist

Cytek Biosciences is at the forefront of cell analysis innovation. Our flagship Full Spectrum Profiling (FSP) technology enables highresolution, high-content analysis by measuring the entire emission spectrum of fluorescent markers-allowing scientists to run complex multiparameter experiments with fewer limitations.
Headquartered in Fremont, California, Cytek has grown its presence globally while maintaining a mission-driven focus: provide next-generation tools, reagents, and software that advance immunology, oncology, cell therapy, and fundamental biological research.

In 2024, Cytek was named "Overall BioTech Company of the Year" by the BioTech Breakthrough Awards, a recognition tied to our commitment to innovation and impact.

The Quality Assurance (QA) department is the guardian of our processes, systems, and compliance practices. It ensures that all product development, manufacturing, and support processes meet strict regulatory standards, including ISO 13485, cGMP, and Good Documentation Practices (GDP).
QA works hand in hand with R&D, Manufacturing, Regulatory, and Operations to embed quality and compliance into every step of bringing instruments, software, and reagents to market. The team supports audits, inspections, training, process control, document management, and continuous improvement initiatives.

As our Senior Document Control & Training Specialist, you will play a pivotal role in maintaining and elevating Cytek's quality infrastructure. You will ensure that policies, procedures, documentation, and training systems reliably meet ISO 13485, cGMP, and GDP requirements. In audit or inspection scenarios, you'll be a critical resource-providing documentation and training records to regulators and certification bodies.

Key Responsibilities

Document Control & Records

• Lead endtoend document control: collaboration, review/approval, release, archival, version control, and training linkage.
• Process engineering change orders (ECOs), manage part number revisions, and validate document changes for completeness and accuracy.
• Edit and format technical documents (SOPs, work instructions, test protocols, BOMs, drawings, travelers, and specs) to ensure consistency, clarity, and compliance.
• Maintain QA logs, databases, and document repositories; support internal and external audits through timely retrieval and presentation of records.
• Oversee records management: scanning, filing, offsite archive, and secure retrieval procedures.
• Develop and monitor metrics and reports relating to document control performance, identify trends, and propose improvements.
• Draft, revise, and maintain SOPs, work instructions, and related documentation in collaboration with stakeholders.
• Provide hands-on training, guidance, and support to users on the document control system, structure, and best practices.
• Cochair change control board meetings; ensure sound documentation structure for clinical or regulated projects.
• Mentor new staff in engineering change documentation practices and the document control lifecycle.

Training & Compliance

• Design, manage, and maintain the training management process under Cytek's QMS (compliant with ISO 13485).
• Develop rolebased training plans, assign required courses, and monitor training completion.
• Track and enforce training compliance metrics; escalate noncompliance and work with departments to close gaps.
• Generate and deliver training reports and metrics to leadership (e.g., compliance rates, overdue training, effectiveness).
• Conduct or facilitate training sessions (on document control, change control, quality systems) and onboard new employees in these practices.

Requirements & Qualifications

Must-haves:

• 5+ years of experience in document control and training management in regulated industries (medical device, biotech, pharmaceutical) under ISO 13485 / cGMP frameworks.
• Direct, hands-on experience with electronic Quality Management Systems (eQMS) such as Propel, MasterControl, or equivalent systems.
• Strong initiative, accountability, and ability to thrive in a fast-paced, changing environment.
• Detail-oriented with excellent editing, formatting, and document structuring skills.
• Solid command of Microsoft Word and Excel (advanced skills preferred).
• Excellent verbal and written communication; comfortable training users and influencing crossfunctional teams.

Nice-to-haves:

• Bachelor's degree in a relevant field (Quality, Regulatory Affairs, Engineering, Life Sciences).
• Experience in clinical or regulated device environments.
• Prior involvement in audits or interfacing with regulatory bodies.
• Experience with multiple eQMS platforms or as a system administrator.
• Familiarity with SOP development, quality metrics, root cause analysis, or compliance programs.

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.

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