Clinical QA Specialist

QA Specialist

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.