Remote GxP QA Specialist - Compliance & Audits

Care Access; United States; Remote; USD 70,000 - 90,000; Full time

Benefits offered by this job

PTO

Health insurance

Dental insurance

Vision insurance

HSA

FSA

401(k) with company match

Disability insurance

Job summary

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support QA and compliance activities. The QA Specialist will monitor the quality and compliance of clinical work at both traditional trial sites and decentralized trials, supporting CAPA systems and inspections readiness.

Working under the Associate Director of Quality Assurance, you will ensure trials follow SOPs, GCP, and FDA/ICH guidelines while promoting a culture of continuous

Qualifications

• Bachelor’s degree in a relevant field.
• 2 years experience in Quality Assurance.
• 4 years experience in Clinical Research in a compliance or GCP role.

Responsibilities

• Ensure patient safety and data integrity at clinical sites.
• Review regulatory binders for GCP compliance.
• Execute annual audit plan and report outcomes.
• Collaborate with staff to resolve CAPA findings.
• Support on-site audits and inspections by external parties.
• Maintain quality systems and SOPs.
• Provide training on quality and improvement activities.
• Assist with regulatory compliance and risk assessments.

Skills

GxP knowledge

GCP familiarity

Attention to detail

Communication

Organizational skills

Team collaboration

Regulatory knowledge

Data integrity

Problem solving

Education

Bachelor’s degree

Tools

Clinical trials database

IVR systems

Electronic data capture

MS Word

Excel

Job description

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support QA and compliance activities. The QA Specialist will monitor the quality and compliance of clinical work at both traditional trial sites and decentralized trials, supporting CAPA systems and inspections readiness.

Working under the Associate Director of Quality Assurance, you will ensure trials follow SOPs, GCP, and FDA/ICH guidelines while promoting a culture of continuous