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Quality Systems Specialist
Job in
Oceanside, San Diego County, California, 92054, USA
Listed on 2026-06-05
Listing for:
Actalent
Full Time
position Listed on 2026-06-05
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
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., Master Control).
+ 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.
Final date to receive applications
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.…
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