Remote GxP QA Specialist – Compliance & Audits

Care Access; Boston (MA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

PTO & Holidays

Medical Dental Vision

HSA & FSA

Employer HSA contributions

Disability Insurance

401(k) Match

Job summary

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support the Quality Assurance Department and ensure clinical work meets SOPs, GCP, and FDA/ICH guidelines.

The role includes QA reviews, CAPA management, audits, and inspections readiness, collaborating with site personnel and Principal Investigators. Remote in the United States with up to 35% travel; compensation reflects $70,000–$90,000 per year.

Qualifications

• Excellent working knowledge of medical and research terminology.
• Excellent working knowledge of federal regulations and good clinical practices (GCP).
• Ability to communicate and work effectively with a diverse team of professionals.
• Strong Organizational Skills: able to prioritize, delegate, direct, support and evaluate others’ work.
• Communication Skills: strong verbal and written communication.
• Team Collaboration Skills: work effectively and collaboratively with other team members.
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS Word and Excel.
• Demonstrate decision making skills; curiosity and passion to learn, innovate, able to communicate 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.

Responsibilities

• Quality & Data Integrity reviews at clinical sites and decentralized trials.
• Regulatory Document Review to verify accuracy and submission per GCP.
• Audit Execution & Tracking with detailed outcome reports.
• CAPA planning and monitoring with research staff and PIs.
• Support on-site audits and inspections by external providers and regulators.
• Quality Systems administration and SOP maintenance.
• Provide training on Quality and Improvement activities.
• Support regulatory and RFP/RFI processes.

Skills

QA Compliance

GxP Knowledge

Regulatory Knowledge

Audits

CAPA Management

Documentation

Cross-functional Collaboration

Data Analysis

Problem Solving

Training Delivery

Remote Collaboration

Tools

Clinical Trials Database

IVR Systems

Electronic Data Capture

MS Word

Excel

Audit Management Software

Job description

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support the Quality Assurance Department and ensure clinical work meets SOPs, GCP, and FDA/ICH guidelines.

The role includes QA reviews, CAPA management, audits, and inspections readiness, collaborating with site personnel and Principal Investigators. Remote in the United States with up to 35% travel; compensation reflects $70,000–$90,000 per year.