Quality Specialist

Green Key Resources; Waltham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Green Key Resources is seeking a Clinical Quality Specialist to support Clinical Quality Operations and ensure compliance with US FDA and European regulations, ICH, and GxP standards. The role is under the direction of the CQA management team, focusing on regulatory readiness and vendor management.

Responsibilities include coordinating audits, assisting in deviations and investigations, generating metrics, and participating in governance meetings.

Qualifications

• Bachelor’s degree or higher in relevant computer, technical, quality, scientific discipline.
• 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.

Responsibilities

• Support auditing processes and audit plans.
• Coordinate investigations, escalation and resolution of issues.
• Assist in scheduling audits with stakeholders.
• Collect and generate metrics for Clinical Quality Operations.
• Participate in meetings/workshops with Site Process Owners and SMEs.
• Assist in deviations, quality investigations and audits.
• Support vendor management database maintenance.

Skills

Quality system processes

MS Word

Excel

Education

Bachelor’s degree or higher in relevant field

Tools

Veeva

TrackWise

ComplianceWire

Job description

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.

• 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