Hybrid Clinical Quality Specialist - Audit & Compliance

Advantage Technical; Waltham (MA); Hybrid; USD 41,000 - 69,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Pet Insurance

401(k) Plan

Employee Assistance Program

Commuter/Parking Accounts

Health Savings Account

AD&D Insurance

Job summary

Advantage Technical is seeking a Clinical Quality Specialist in Waltham, MA, offering a hybrid schedule with 3-5 days onsite. The role supports clinical research operations, quality systems, audits, and inspection readiness in a fast-paced pharmaceutical environment.

Ideal candidates have a Bachelor's in a scientific/healthcare field and 3–6 years of related experience, with strong knowledge of FDA regulations and GxP.

Qualifications

• Bachelor's degree in a scientific, technical, quality, healthcare, or related field
• 3-6 years of experience in pharmaceutical, CRO, clinical research, or healthcare environments
• Knowledge of FDA regulations, ICH guidelines, GxP requirements, and regulatory compliance standards
• Proficiency with Word and Excel; familiarity with quality systems (Veeva, TrackWise, ComplianceWire)

Responsibilities

• Support audit reports, audit plans, change controls, deviations, and quality documentation
• Coordinate quality investigations, issue resolution, and corrective actions
• Schedule and support internal and external audits
• Collect, track, and report Clinical Quality metrics
• Assist with inspection readiness and regulatory compliance activities
• Support vendor management processes and database maintenance
• Track project status updates and quality action items
• Participate in process improvement initiatives and quality meetings
• Assist with employee onboarding and training coordination

Skills

FDA regulations

ICH guidelines

GxP compliance

Quality systems

Copilot familiarity

Education

Bachelor's degree

Tools

Veeva

TrackWise

ComplianceWire

Microsoft Office

Job description

Advantage Technical is seeking a Clinical Quality Specialist in Waltham, MA, offering a hybrid schedule with 3-5 days onsite. The role supports clinical research operations, quality systems, audits, and inspection readiness in a fast-paced pharmaceutical environment.

Ideal candidates have a Bachelor's in a scientific/healthcare field and 3–6 years of related experience, with strong knowledge of FDA regulations and GxP.