Senior Quality Systems & Change Control Specialist

Actalent; Foster City (CA); Hybrid; USD 62,000 - 90,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance (Voluntary Life & AD&D)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave

Job summary

Actalent, a global leader in engineering and sciences services, seeks a Quality Systems Specialist in Foster City, CA. The role focuses on managing change control, ensuring cGMP compliance, and driving quality improvements in GxP environments.

You will lead cross-functional reviews, document decisions, and mentor junior staff while maintaining quality system metrics and supporting audits.

Qualifications

• Six+ years in change control within a GxP/GMP environment.
• BS/BA in scientific/technical discipline with cGMP experience in biologics.
• Experience writing and implementing controlled documents (SOPs, specs, methods).

Responsibilities

• Manage and document change controls across products, processes, equipment, and systems.
• Review and initiate change controls in local and global GxP systems.
• Lead cross-functional meetings to align on changes and ensure compliance.
• Guide complex change reviews and document decisions and rationales.
• Monitor change records and maintain tracking tools and databases.
• Develop quality system metrics and trending reports for management reviews.
• Support continuous improvement of quality systems processes.
• Provide guidance to junior staff in quality systems and change control.
• Assist audits with documentation and explanations.

Skills

Change control

GxP operations

cGMP knowledge

Quality assurance

Documentation control

SOPs and specs writing

Cross-functional teamwork

Mentorship for junior staff

Biologics knowledge

Education

BS or BA in a scientific or technical discipline

Tools

Change management systems

Document management platforms

Quality metrics tools

Job description

Actalent, a global leader in engineering and sciences services, seeks a Quality Systems Specialist in Foster City, CA. The role focuses on managing change control, ensuring cGMP compliance, and driving quality improvements in GxP environments.

You will lead cross-functional reviews, document decisions, and mentor junior staff while maintaining quality system metrics and supporting audits.