GCP QA Specialist

Location: Fully Remote (U.S.). Travel: Up to 25% Domestic and International. TRI approved states: AZ, FL, GA, IA, IL, KS, MA, MD, NC, TN, TX, VA, WV, Washington D.C. Job Type: Contract to Hire (based out of Bethesda, MD).

About the role

We are seeking a detail-oriented GCP QA Specialist to support our Clinical Quality Assurance team and ensure compliance with Good Clinical Practice (GCP) requirements across clinical operations. This role will be responsible for supporting quality systems, audit activities, document control processes, and regulatory inspection readiness while contributing to continuous improvement initiatives. This is an excellent opportunity to join a growing organization that values employee development, promotes from within, and offers the flexibility of a fully remote work environment.

Responsibilities

• Support the maintenance, administration, and continuous improvement of the Quality Management System (QMS).
• Maintain Quality Assurance programs, including: Training management, Document control, Customer complaint management, Corrective and Preventive Action (CAPA) program.
• Support internal, external, and clinical site audits.
• Assist with audits of clinical sites, vendors, and suppliers to ensure compliance with applicable regulations and quality standards.
• Support the internal audit program and quality performance metrics to drive continual improvement.
• Coordinate QA-controlled document review cycles to ensure procedures remain current and aligned with operational practices.
• Assist in preparing for and supporting regulatory agency audits and inspections.
• Collaborate with cross-functional teams to maintain compliance and strengthen quality processes.

Qualifications

• Working knowledge of current Good Clinical Practice (GCP) regulations.
• Experience supporting quality assurance activities within a clinical research, pharmaceutical, biotechnology, or CRO environment.
• Experience participating in internal, external, and site audits.
• Familiarity with Quality Management Systems (QMS).
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications.
• Ability to manage multiple priorities and work effectively in a remote environment.
• Experience supporting regulatory agency audits and inspections.
• Experience working with Quality Systems within a CRO environment.
• Familiarity with CAPA processes and quality investigations.
• Experience with vendor qualification and oversight activities.

Pay

The pay range for this position is $40.00 - $58.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

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).