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Job Summary:

The Quality Systems (QS) Specialist I is responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), which helps to ensure compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS.

Key Accountabilities:

Support activities within the Quality Systems team, with primary responsibility for at least one of the following:

CAPA process: tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities.

Deviation process: tracking, trending, and driving timely/appropriate closure.

Internal Audit program: transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure.

Quality Plans: issuing number, tracking status, appropriate closure.

Quality Records: scan, inventory, archive and retrieve quality records; maintain off-site master inventory list.

Design Control: support the DHF/DCR creation, maintenance, and archival process; conduct DHF/DCR reviews/audits; act as an independent reviewer during design review.

Quality Systems Activities:

+ CAPA

+ Deviation process

+ External Document process

+ Quality Agreements

+ International QMS compliance with Werfen Affiliates

+ Quality Plans

+ Training program

+ Facilitate meetings related to QS activities by taking minutes as directed.

+ Support change orders/process improvements with respect to Quality Management System procedures with direction from management.

+ Provide support to quality assurance activities for regulatory compliance (e.g., Management Review support, Regulatory audits).

+ Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs.

+ Participate in internal, external, and/or 3rd party audits, as needed.

+ Provide support through a general working knowledge of all Werfen Quality System programs.

+ Aid employees based on a clear understanding and implementation of regulatory standards.

+ Carry out duties in compliance with established business policies.

+ Interface with all functions and levels of management as needed.

+ Maintain the accuracy, legibility, traceability, and retrieval of quality documents and records.

+ Other duties as assigned, according to the changing needs of the business.

Skills

record retention, FDA compliance, GMP, GDP, change control, CAPA, audit support

Top Skills Details

record retention, FDA compliance, GMP, GDP, change control, CAPA

Additional Skills & Qualifications

•Bachelor’s degree (Life Sciences) preferred.

•Minimum of two (2) years relevant experience or one (1) year related experience with an advanced degree required.

•Previous Quality Assurance experience within a GMP regulated environment required.

Experience Level

Intermediate Level

Job Type & Location

This is a Contract position based out of San Diego, CA.

Pay and Benefits

The pay range for this position is $33.65 - $40.87/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 San Diego,CA.

Application Deadline

This position is anticipated to close on Jan 22, 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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.