Clinical Quality Specialist

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

Now Hiring: Clinical Quality Specialist

Location: Waltham, MA
Schedule: Hybrid, 3-5 days per week onsite
Pay Rate: Up to $50.00/hour

Looking to grow your career in clinical quality and regulatory compliance? We're seeking a Clinical Quality Specialist to support clinical research operations, quality systems, audit activities, and inspection readiness in a fast-paced pharmaceutical environment. This opportunity offers hands‑on experience with quality processes that support critical clinical studies.

Education Requirements

Bachelor's degree in a scientific, technical, quality, healthcare, or related field

Experience Requirements

• 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 Microsoft Office, including Word and Excel
• Experience with Veeva, TrackWise, ComplianceWire, or similar quality systems preferred
• Familiarity with Microsoft Copilot is a plus

Job Duties

• 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

Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD&D Insurance

If you're detail-oriented, quality-focused, and ready to make an impact in clinical research operations, for this exciting opportunity.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

About Us

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.