Clinical Quality Assurance Specialist

Job Title:

Clinical Quality Assurance Specialist

Job Description

The Clinical Quality Assurance Specialist supports the maintenance and enhancement of the Quality Management System. This role is vital in maintaining the QA training program, document control, customer complaint program, and CAPA program. The specialist assists in audits of clinical sites and vendors/suppliers, supports the internal audit program, and contributes to the performance metrics system for continual improvement. Additionally, this position manages the review cycle of QA controlled documents to ensure practices align with written procedures, and supports regulatory agency audits.

Responsibilities

+ Support the maintenance and enhancement of the Quality Management System.

+ Maintain the QA training program, document control, customer complaint program, and CAPA program.

+ Assist in audits of clinical sites and vendors/suppliers.

+ Support the internal audit program and performance metrics system for continual improvement.

+ Manage the review cycle of QA controlled documents to ensure alignment with written procedures.

+ Support regulatory agency audits.

Essential Skills

+ Knowledge of current GCP regulations.

+ Experience working with regulatory agency audits.

+ Experience working with Quality Systems for CROs.

+ Excellent written and verbal communication skills.

+ Proficiency in MS Office.

Additional

Skills & Qualifications

+

Experience with internal, external, and site audits.

+ Familiarity with audit processes and Quality Systems.

Work Environment

This position offers the opportunity to grow within an organization that values internal promotions. The role is primarily remote, with the exception of necessary audit travel. Candidates must reside in Maryland, DC, Virginia, or North Carolina. The position requires up to 25% travel, both domestically and internationally.

Job Type & Location

This is a Contract to Hire position based out of Raleigh, NC.

Pay and Benefits

The pay range for this position is $40.00 - $58.00/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 remote position.

Final date to receive applications

This position is anticipated to close on Jul 3, 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 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 Clearly Rated 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 actalentaccom 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.