GCP QA Specialist

GCP QA Specialist Location: Fully Remote (U.S.) Travel: Up to 25% Domestic and International Travel 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. Key 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. Required 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. Job Type & Location This is a Contract to Hire position based out of Bethesda, MD. Pay and Benefits 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. 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 Sep 23, 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 ClearlyRated 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 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.