Clinical QA Specialist: cGMP & Continuous Improvement

Piper Companies; Philadelphia (Philadelphia County); Hybrid; USD 55,000 - 62,000; Full time

Benefits offered by this job

Hybrid schedule

Medical, Dental, Vision

401K, PTO, Holidays

Job summary

Piper Companies is seeking a Quality Assurance Specialist to join a life sciences organization in the Greater Philadelphia area. The role focuses on batch disposition, quality systems oversight, and adherence to cGMP standards to support worldwide clinical studies.

You will review materials, support investigations, CAPAs, deviation management, and change controls, and collaborate with cross-functional teams to ensure compliant clinical packaging, labeling, distribution, and supply chain

Qualifications

• Bachelor’s degree in a scientific, engineering, or related technical field preferred.
• 5+ years of experience in a GMP-regulated pharmaceutical/biotech environment.
• Experience with batch disposition, batch release, or clinical material review preferred.
• Knowledge of investigations, deviation management, CAPAs, and change controls.
• Strong understanding of cGMP regulations and pharmaceutical quality systems.

Responsibilities

• Review and disposition clinical supply materials to ensure compliance with procedures, cGMPs, and regulatory requirements.
• Perform batch documentation reviews and support release activities for clinical finished goods used in global trials.
• Assist with quality investigations, deviations, CAPAs, and change control activities.
• Support continuous improvement initiatives, quality process enhancements, and procedural updates.
• Partner with cross-functional teams to ensure compliant clinical packaging, labeling, distribution, and supply chain operations.
• Provide quality guidance and support for operational and technical issues.
• Manage investigation and project timelines while identifying risks and supporting remediation efforts.
• Active usage of Lean Six Sigma and PS tools in problem solving.

Skills

Analytical skills

Problem-solving

Communication

Organizational skills

Education

Bachelor's degree in science/engineering or related field

Tools

TrackWise

SAP

Veeva

Documentum

QUMAS

ERP

MES

Job description

Piper Companies is seeking a Quality Assurance Specialist to join a life sciences organization in the Greater Philadelphia area. The role focuses on batch disposition, quality systems oversight, and adherence to cGMP standards to support worldwide clinical studies.

You will review materials, support investigations, CAPAs, deviation management, and change controls, and collaborate with cross-functional teams to ensure compliant clinical packaging, labeling, distribution, and supply chain