Job Description

Job Description

Job Description

Job Title: Quality Systems Specialist

Job Description

The Quality Systems Specialist is responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems. This role requires adherence to key performance indicators and a commitment to 'right the first time' principles. The specialist will independently review, initiate, complete, and document critical, major, and minor change controls, managing both local and global change controls and associated activities in GxP operations.

Responsibilities

• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations.
• Navigate complex change review discussions, facilitating decisions regarding approach and follow-up actions, and document these evaluations.
• Support management and monitoring of change records for adherence to organizational or departmental metric targets and maintain associated tracking tools and databases.
• Assist in the management review process by developing and generating quality system metrics and trends, escalating issues as necessary.
• Contribute to the maintenance and improvement of quality systems processes as needed.
• Collaborate directly with operating entities and internal clients to ensure follow-up on change tasks.

Essential Skills

• 6+ years of relevant experience in a GMP environment for biologics manufacturing with a BS or BA, including mandatory change control experience.
• 4+ years of relevant experience with a MS degree.
• Change control experience from a regulated industry such as medical device, pharma, nutraceuticals, or vitamins, with FDA-related knowledge.
• Strong communication skills, good time management skills, and attention to detail.
• Knowledge of good technical writing.

Work Environment

The role offers a hybrid work environment with required onsite presence on Tuesdays, Wednesdays, and Thursdays, while offering work-from-home flexibility on Mondays and Fridays. This position provides an opportunity to work with end-to-end change control management in a streamlined capacity for the organization. Initially a one-year role with potential for renewal based on business needs.

Job Type & Location

This is a Contract position based out of Foster City, California

Pay and Benefits

The pay range for this position is $50.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Foster City,CA.

Application Deadline

This position is anticipated to close on Nov 5, 2025.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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