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Clinical QA Specialist
- Actalent (Raleigh, NC)
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Job Title: QA Specialist
Job Description
We are seeking a Clinical QA Specialist to join our team, to assist in conducting both internal and external audits within GCP guidelines.
Responsibilities
+ Conduct clinical site audits, both domestic and international, to verify regulatory compliance and protocol adherence.
+ Verify compliance with applicable Standard Operating Procedures (SOPs) and regulations.
+ Review clinical audit reports and provide guidance to auditors.
+ Support the inspection readiness program.
+ Serve as a subject matter expert for quality.
+ Promote quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System.
+ Host client audits and conduct external audits at clinical and vendor sites.
+ Lead process improvement activities and CAPA investigations.
+ Support regulatory authority inspections.
Essential Skills
+ Solid understanding and working knowledge of GCP with a minimum of 5 years of experience, or 3+ years with strong supporting experience.
+ Experience working with eQMS.
+ Proficiency in MS Office.
+ Experience with supervising staff.
Additional Skills & Qualifications
+ Minimum of a B.S/B.A. degree.
+ Certified Quality Auditor (CQA) preferred.
+ Advanced degree preferred.
Work Environment
The position offers flexibility with a hybrid work environment: 2 days onsite and 3 days working from home, or fully remote. Remote candidates must reside in North Carolina, Virginia, Washington D.C., or Maryland. The role includes travel 10-20% of the time, with one domestic trip every other month.
Job Type & Location
This is a Contract to Hire position based out of Bethesda, Maryland.
Pay and Benefits
The pay range for this position is $43.27 - $55.28/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.
Application Deadline
This position is anticipated to close on Oct 22, 2025.
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.
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