Document Control/quality Assurance Specialist

Job Description

The Quality Systems Specialist manages, coordinates, facilitates, and implements quality system processes to ensure compliance with cGMP, ICH, ISO, and internal quality standards. This role supports core Quality Management System activities including document control, training administration, audits, controlled documentation updates, and quality systems compliance.

Responsibilities

• Maintain procedures and work instructions to ensure compliance with quality standards.
• Track training assignments and compliance for all relevant personnel.
• Support internal, supplier, and customer audits to ensure readiness and compliance.
• Coordinate customer quality documentation requests effectively.
• Participate actively in change controls, deviations, and CAPA-related activities.
• Assist with quality metrics and trend reporting to support continuous improvement.
• Collaborate cross-functionally with internal departments, customers, and suppliers to resolve quality-related issues and enhance quality system effectiveness.

Essential Skills

• Hands-on experience supporting or maintaining a Quality Management System within a regulated GxP, cGMP, and/or ISO-controlled manufacturing environment.
• Experience with document control processes, including creating, revising, reviewing, routing, approving, and maintaining SOPs, work instructions, forms, and other controlled quality documents.
• Familiarity with maintaining documentation accuracy and traceability.
• Experience supporting audit readiness and quality system processes such as internal audits, supplier/customer audits, training program administration, training compliance tracking, change control, deviations, and CAPA activities.

Additional Skills & Qualifications

• Bachelor's degree in a scientific discipline or related field, or an equivalent combination of education and experience.
• 3–4 years of experience supporting Quality Systems and/or Quality Assurance in a regulated GxP and/or ISO-controlled manufacturing environment.
• Strong written documentation skills.
• Ability to manage controlled documents with accuracy and attention to detail.
• Experience supporting training systems and compliance tracking.
• Ability to coordinate multiple quality system activities simultaneously.
• Strong cross-functional communication and organizational skills.
• Comfort working within established procedures while supporting continuous improvement.
• Audit preparation/support experience preferred.
• Experience with CAPA, deviations, and change control processes preferred.

Work Environment

The work schedule is Monday through Friday from 8 AM to 5 PM, with some flexibility. Some travel to Oceanside and Carlsbad may be required. The role provides an opportunity to lead and shape a growing QMS function within a regulated manufacturing environment, with ownership of a high-impact digital transformation (MasterControl implementation). The position offers high visibility, interacting with leadership and regulatory bodies, and the ability to build and develop a team while driving continuous improvement initiatives. Exposure to cross-functional operations across quality, manufacturing, and other disciplines is also included.

This is a Contract position based out of Carlsbad, CA.

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)

This is a fully onsite position in Carlsbad,CA.

This position is anticipated to close on Jun 10, 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.

Salary : $27 - $35