Quality 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

Pay range: 40-50/hr

• depending on exp

The Clinical Quality Specialist, under the direction of the CQA management team, will be responsible to support Clinical Quality and their operations in ensuring compliance of clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements.

Position Details

• Support the processing of audit reports, change controls, deviation, and audit plans


• Support CQA team in the coordination, investigation, escalation, and resolution of issues identified during Clinical Quality Operations


• Support scheduling of audits with internal and external stakeholders


• Collect and generate metrics for Clinical Quality Operations.


• Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEs


• Participate in CQA meetings and the additional forums including but not limited to Inspection Readiness and Regulatory Inspections


• Assist Clinical Quality in supporting internal and external stakeholders in the processing of deviations, Quality Investigations, and audits


• Follow-up on requests, issues, and projects and report statuses to manager and CQA team


• Support the management and maintenance of the Clinical Quality Vendor Management database.


• Provide CQA support through training management and onboarding of new employees.

Academic/Technical Qualifications

• Bachelor’s degree or higher in relevant computer, technical, quality, scientific discipline, preferably multi-disciplinary with a strong technical and quality background


• Minimum of 3-6 years of experience in commercial pharma, CRO, clinical pharma, or healthcare facility


• Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva, TrackWise, and ComplianceWire is a plus.


• Understanding and working knowledge of US FDA and European regulatory requirements. Knowledge of Regulatory Compliance, ICH Guidelines, GxP standards


• Familiarity with Co-Pilot a plus