Quality Systems Specialist

Job Title : Quality Systems Specialist

Location : Menlo Park, CA (100% Onsite)

Experience : 4+ years

Duration : 12+ months

Summary :

A biotech company is seeking a Quality Systems Specialist with strong expertise in administering the MasterControl electronic Quality Management System (eQMS). This role will lead the configuration, maintenance, and optimization of MasterControl, ensuring the system supports regulatory compliance and organizational quality standards.

Responsibilities :

Serve as the primary system administrator and business owner for MasterControl eQMS.

Lead system configuration, user management, and workflow optimization within MasterControl.

Maintain document control standards and manage quality workflows in the system.

Provide end-user support, training, and troubleshooting for MasterControl modules.

Ensure compliance with GxP and industry regulations (GMP, ISO 13485, ICH, etc.) through effective system use.

Support vendor management activities and perform additional QA system tasks as needed.

Qualifications :

4+ years of life sciences experience with a focus on Quality Systems.

4+ years of hands-on experience as a MasterControl eQMS Administrator.

Strong knowledge of document control, training, and other quality system modules within MasterControl.

Familiarity with ICH guidelines, ISO 9001 / 13485, and GMP regulations.

Clear and professional communication skills, including experience delivering user training.

Bachelor's degree in a life science or related discipline.