Specialist, Quality Assurance

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support the success of the Quality Assurance Department and organizational compliance activities. The Quality Assurance Specialist will be responsible for closely monitoring the quality and compliance of clinical work at both traditional trial sites and decentralized trials.QA specialist will directly support of quality initiatives, audit functions, CAPA systems and promote inspections readiness.  Working in support of the Associate Director of Quality Assurance, the Quality Assurance Specialist will ensure that Care Access maintains a high level of quality while executing clinical trials according to Care Access SOPs, GCP, and FDA/ICH Guidelines.  

• Site-Level Quality & Data Integrity: Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews, site quality support, and assurance compliance with Standard Operating Procedures. 
• GCP Regulatory Document Review: Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify they are accurately completed and maintained per GCP standards. 
• Audit Execution & Tracking: Execute the yearly corporate audit plan, systematically tracking quality assurance audits, monitoring related activities, and preparing detailed outcome reports for management. 
• Issue Resolution & CAPA Management: Partner directly with research staff and Principal Investigators (PIs) to resolve identified compliance issues, developing, tracking, and monitoring Corrective and Preventative Action (CAPA) plans. 
• External Audit & Inspection Support: Coordinate and provide hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory agencies. 
• Quality Systems Administration: Provide ongoing administrative support to the Quality Department by maintaining internal quality systems, compliance trackers, and operational programs. 
• SOP Development & Maintenance: Participate in the routine review, drafting, and maintenance of quality assurance Standard Operating Procedures (SOPs) to ensure alignment with evolving regulations. 
• Cross-Functional Compliance Advisory: Act as an internal quality resource to provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams. 
• Regulatory compliance: be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidance’s such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3).  
• Inspection readiness: promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities.
• Create and deliver training on Quality and Improvement activities  
• Support completion of RFP/RFI (Request for proposals/information) 
• Willingness to learn and engage with digital technologies  
• Provide AI project quality support and consultation 
• Support other activities related to the management of QMS and accuracy of data 
• Support GxP and non GxP quality issues and/or projects needing quality consultation and support    

• Ability to work independently, remain objective, and manage multiple assignments.  
• Remain flexible and work in evolving regulatory environments. 
• Display an openness to innovative and compliant approaches to conducting research and health services activities 
• Technical proficiency is required to work daily in QMS and utilize various software and platforms across the business. 
• Ability to drive change and demonstrate impact across the business.  
• Excellent writing and presentation skills and ability to lead and coach staff and cross-functional teams.  
• Excellent working knowledge of medical and research terminology 
• Excellent working knowledge of federal regulations and Good Clinical Practices (GCP) 
• Attention to detail 
• Ability to communicate and work effectively with a diverse team of professionals 
• Strong Organizational Skills 
• Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors 
• Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals 
• Demonstrate decision making skills 
• Curiosity and passion to learn, innovate, able to communicate any possible risks and get things done 
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure 
• High level of self-motivation and energy 
• Ability to work independently in a fast-paced environment with minimal supervision 
• Must have a client service mentality 
• Experience with supporting multiple sites and identifying gaps 
• Experience with internal and external audits: FDA, GCP, SOPs 
• Experience with supporting multiple sites and identifying improvement gaps