Clinical Quality Assurance Specialist (CQA)

Planet Pharma; Waltham (MA); On-site; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma is seeking a Clinical Quality Specialist in Waltham, MA to support Clinical Quality Operations and vendor management in alignment with US FDA, ICH, and GxP standards. You will assist audit planning, deviation investigations, and inspection readiness.

Ideal candidates have a Bachelor’s degree and 3–6 years in pharma/CRO settings, with proficiency in MS Word/Excel and quality systems; experience with Veeva or TrackWise is a plus. On-site role with competitive pay.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 3–6 years of experience in commercial pharma, CRO, or clinical healthcare settings.
• Proficient in MS Word, Excel, and Quality System processes.
• Familiarity with US FDA, ICH guidelines, and GxP standards.

Responsibilities

• Support processing of audit reports, deviation, and audit plans.
• Assist in coordinating investigations, escalation, and resolution of issues.
• Schedule audits with internal and external stakeholders.
• Collect and generate metrics for Clinical Quality Operations.
• Participate in workshops with Site Process Owners and SMEs.
• Attend CQA meetings and inspection readiness forums.
• Support processing of deviations, investigations, and audits.
• Follow-up on requests and report statuses to management.
• Maintain the Clinical Quality Vendor Management database.
• Provide training management and onboarding support.

Skills

Regulatory knowledge

Quality mindset

Attention to detail

Education

Bachelor’s degree or higher in relevant field

Tools

MS Word

Excel

Quality System processes

Veeva

TrackWise

ComplianceWire

Job description

Planet Pharma is seeking a Clinical Quality Specialist in Waltham, MA to support Clinical Quality Operations and vendor management in alignment with US FDA, ICH, and GxP standards. You will assist audit planning, deviation investigations, and inspection readiness.

Ideal candidates have a Bachelor’s degree and 3–6 years in pharma/CRO settings, with proficiency in MS Word/Excel and quality systems; experience with Veeva or TrackWise is a plus. On-site role with competitive pay.