Qms Specialist- Change Control Management

Job Title: Quality Systems Specialist Job Description
The Quality Systems Specialist manages and improves change control and quality systems within a GMP/GxP manufacturing environment. This role oversees change controls for products, processes, equipment, facilities, and computerized systems, ensuring compliance with quality management system expectations and current Good Manufacturing Practices. The specialist facilitates cross-functional alignment, supports quality metrics and management review processes, and helps maintain high standards for documentation and controlled procedures.
Responsibilities
- Manage change controls related to manufacturing products, processes, equipment, facilities, and computerized systems, contributing to key strategic, tactical, and operational quality goals.
- Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls for both local and global activities in GxP operations.
- Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with quality management system expectations.
- Navigate complex change review discussions, guide teams to a common decision on approach and follow-up actions, and document all evaluations and decisions accurately.
- Support the management and monitoring of change records to ensure adherence to organizational and departmental metric targets, maintaining associated tracking tools and databases.
- Develop and generate quality system metrics and trending to support the management review process, and escalate issues when required.
- Support the maintenance and continuous improvement of quality systems processes as needed.
- Work directly with operating entities and internal partners to ensure timely follow-up and completion of change-related tasks.
- Participate in compliance audits as required, providing documentation and subject matter expertise on change control and quality systems.
- Maintain programs and processes that ensure high-quality products and compliance with current Good Manufacturing Practices (cGMPs).
- Write and implement changes to controlled documents such as standard operating procedures, specifications, and methods as needed.
- Provide guidance and technical knowledge to more junior staff and monitor the performance of their daily tasks.
- Lead trainings and presentations for groups of approximately 30 or more participants on quality systems and change control processes.
Essential Skills
- Minimum of six years of change control experience in a GxP environment.
- 6+ years of relevant experience in a GMP environment for biologics manufacturing with a BS or BA degree.
- Strong quality assurance background with hands-on experience in document control and change control processes.
- Demonstrated ability to independently manage, document, and close complex change controls across local and global operations.
- Good communication and presentation skills, including the ability to lead trainings for groups of 30 or more people.
- Technical science degree (BS or BA) from a scientific or technical background.
- Proven experience working within cGMP and GxP quality systems.
- Ability to facilitate cross-functional meetings and drive consensus on change-related decisions.
- Strong attention to detail and accuracy in documentation and record-keeping.
- Ability to analyze and generate quality system metrics and trends, and to support management review activities.
Additional Skills & Qualifications
- Experience with biologics manufacturing is highly preferred.
- Experience with both small molecule and large molecule products is beneficial.
- Ability to mentor and provide technical guidance to junior staff.
- Comfort working with tracking tools and databases for change control and quality metrics.
- Experience participating in compliance audits and supporting audit readiness.
- Strong organizational skills and the ability to manage multiple change records and tasks simultaneously.
Work Environment
The role operates in a regulated GMP/GxP manufacturing environment focused on biologics and other pharmaceutical products. The Quality Systems Specialist collaborates closely with cross-functional teams, stakeholders, and leadership, often participating in structured meetings and formal training sessions for larger groups. Work involves extensive use of computerized systems, quality management tools, and documentation platforms to manage change records, metrics, and controlled documents. The environment emphasizes adherence to cGMP standards, robust documentation practices, and continuous improvement of quality systems processes.
Job Type & Location
This is a Contract position based out of Foster City, CA.
Pay and Benefits
The pay range for this position is $45.00 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)
Job Type & Location
This is a Contract position based out of Foster City, CA.
Application Deadline
This position is anticipated to close on Nov 26, 2026.
Workplace Type
This is a hybrid position in Foster City,CA. About Actalent

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability,
please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.