QUALITY SPECIALIST, CQA

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

Job summary

Planet Pharma seeks a Clinical Quality Specialist, CQA, in Waltham, MA to support clinical quality operations, vendor management, and inspection readiness under CQA leadership. The position requires familiarity with FDA/ICH/GxP, and experience with QA systems and audits.

The role involves coordinating audits, managing deviation investigations, and contributing to training and onboarding of new staff. Hybrid work model offered; compensation details available on request.

Qualifications

• Bachelor’s degree or higher in a relevant computer, technical, quality, scientific discipline.
• 3–6 years of experience in commercial pharma, CRO, clinical pharma, or healthcare facility.
• Proficient in MS Word and Excel; familiarity with Quality System processes.

Responsibilities

• Support processing of audit reports, change controls, deviations, and audit plans.
• Coordinate, investigate, escalate, and resolve issues in Clinical Quality Operations.
• Schedule audits with internal and external stakeholders.
• Collect and generate metrics for Clinical Quality Operations.
• Participate in meetings with Site Process Owners and business SMEs.

Skills

MS Word

MS Excel

Quality System

Regulatory Understanding

Education

Bachelor’s degree or higher in relevant field

Tools

Veeva

TrackWise

ComplianceWire

Job description

Quality Specialist, CQA
Location: Waltham, Massachusetts
Category: Quality and Compliance
Salary: Apply for details
Country: United States
Employment: Contract
Worksite: Hybrid

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

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.