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

The Senior Document Control and Training Specialist will support the Quality department in ensuring that company policies and procedures, document control, record-keeping, and training processes conform to ISO 13485, cGMP, and GDP requirements. This individual will be responsible for providing documents and training records during ISO 13485 certification audits and FDA inspections. Prior experience with eQMS, like Propel, is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Document Control:

• Lead the document control process for the company by controlling documentation for collaboration, approval, release, archival, and training.
• Independently performs day-to-day Document Control activities: Process Change Order packages, releasing or revising engineering part numbers, and review for correctness and completeness; monitor and update in-process documents.
• Process deviations promptly.
• Edit, format new or revised test records, procedures, drawings, BOMs, travelers, and specifications submitted to Doc Control, as applicable.
• Update and maintain Document Control logs and databases.
• Assist with audits, both internal and external.
• Perform duties in support of established records management procedures, including scanning, filing, and managing off-site records storage and retrieval.
• Assist in the preparation of document control metrics and reports.
• Initiates SOP updates.
• Initiates creation of new SOPs and Work Instructions about Doc Control.
• Provide user assistance and training on document control systems and procedures.
• Lead the ECs and documentation structure for clinical projects.
• Co-Chair the Change Control Board meetings.
• Help train new employees in writing an EC.

Training:

• Lead the training management process as required by ISO 13485 and the Quality Management System.
• Responsible for assigning training for onboarding of new employees, suspending and resuming training for employees on Leave of Absence, and removing training for employee separations. This requires communication with HR and managers globally.
• Create training plans for different departments and assign training.
• Monitor the completion of training to close the related EC training task and help to reach the training compliance KPI set by the company.
• Run monthly Open training reports for email communication to employees and managers.
• Generate regular metrics and report to leadership.

REQUIREMENTS & QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• 7+ years of Document Control and Training Management experience in a regulated environment (e.g., ISO 13485 or FDA cGMP)
• Hands-on experience with eQMS like Propel, Mastercontrol, or any other document control system.
• Hands-on experience with training presentation and managing training on QMS for all employees.
• Must have demonstrated initiative and accountability in a fast-paced environment.
• Bachelor's Degree Preferred.

ADDITIONAL SKILLS AND COMPETENCIES:

• Proactively communicates information or issues that may impact product quality or costs of manufacturability to all affected departments
• Working knowledge of Quality Systems, GMP-related requirements, and ISO standards, desirable
• Detail-oriented with solid problem-solving acumen and ability to work effectively in a team environment
• Strong MS Office skills required. Very strong MS Word and Excel skills
• Excellent verbal and written communication and interpersonal skills

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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