Quality Systems Specialist

Quality Systems Specialist Overview The Quality Systems Specialist is responsible for managing and maintaining Quality Management System (QMS) processes to ensure compliance with cGMP, GxP, ICH, ISO, and internal quality standards within a regulated manufacturing environment. This role plays a key part in supporting core QMS functions—including document control, training administration, audits, and compliance activities—while partnering cross-functionally to resolve quality issues, support continuous improvement initiatives, and enhance overall system effectiveness. Key Responsibilities Manage and maintain the Quality Management System (QMS) to ensure regulatory and internal compliance. Coordinate quality system processes such as document control, training administration, audit support, and compliance tracking. Author, revise, review, route, and maintain controlled documents (SOPs, work instructions, and forms). Ensure document accuracy, consistency, and traceability throughout the document lifecycle. Track and monitor training assignments and compliance; support training system administration. Support audit readiness and participate in internal, supplier, and customer audits. Coordinate and fulfill customer quality documentation requests in a timely manner. Participate in change control, deviation investigations, and CAPA processes (documentation, tracking, and follow-up). Develop and monitor quality metrics and trend reports to drive continuous improvement. Collaborate cross-functionally with internal teams, customers, and suppliers to resolve quality issues. Support digital transformation initiatives and QMS system enhancements (e.g., eQMS platforms). Manage multiple priorities in a fast-paced, regulated environment with a high level of detail and organization. Provide high-visibility support for leadership and regulatory interactions. Required Qualifications 3+ years of experience supporting Quality Systems or Quality Assurance in a regulated GxP, cGMP, and/or ISO-controlled environment. Hands-on experience with Quality Management Systems (QMS) and quality system processes. Strong knowledge of document control processes and controlled documentation lifecycle. Experience with audits (internal, supplier, customer) and audit preparation. Familiarity with training administration and compliance tracking. Exposure to CAPA, deviation management, and change control processes. Bachelor's degree in a scientific discipline or related field (or equivalent experience). Excellent written documentation skills with strong attention to detail. Strong organizational and cross-functional communication skills. Preferred Qualifications Experience in pharmaceutical or highly regulated manufacturing environments. Knowledge of cGMP, GxP, GDP, ISO 9001, and ICH guidelines. Experience with electronic QMS platforms (e.g., MasterControl). Expirience in CAPA management, deviation investigations, and structured change control. Exposure to Six Sigma or continuous improvement methodologies. Experience supporting or leading audit activities and regulatory interactions. Interest in digital transformation and continuous improvement initiatives. Work Environment This role operates within a regulated GxP and/or ISO-controlled manufacturing environment and is primarily onsite. The position requires strong collaboration with Quality, Operations, customers, and suppliers and the ability to manage multiple priorities in a fast-paced setting. This is a high-impact opportunity to: Contribute to and enhance a growing QMS function Support digital transformation initiatives Gain visibility with leadership and regulatory stakeholders Drive continuous improvement across the organization Job Type & Location This is a Contract position based out of Oceanside, CA. Pay and Benefits The pay range for this position is $27.00 - $35.00/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 fully onsite position in Oceanside,CA.

Application Deadline This position is anticipated to close on Jun 16, 2026. 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 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 process due to a disability, please email actalentaccommodation@actalentservices.com 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.