Quality Assurance Specialist

About the role

Piper Companies is seeking a Quality Assurance Specialist to join a leading pharmaceutical organization supporting global clinical trial operations located in Lansdale, PA. The Quality Assurance Specialist will play a key role in ensuring the quality and compliance of clinical supply materials through batch disposition activities, quality systems oversight, and adherence to cGMP standards supporting worldwide clinical studies.

Responsibilities

• Review and disposition clinical supply materials to ensure compliance with company procedures, cGMP regulations, and regulatory requirements.
• Perform batch documentation reviews and support release activities for clinical finished goods used in global clinical 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 the company’s production system tools within problem solving and daily activities.

Qualifications

• Bachelor’s degree in a scientific, engineering, or related technical field preferred.
• 5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related industry environment.
• Experience with batch disposition, batch release, or clinical material review strongly preferred.
• Knowledge of investigations, deviation management, CAPAs, and change controls.
• Background in Quality Assurance, Quality Control, Regulatory Affairs, Technical Operations, or Manufacturing Quality.
• Strong understanding of cGMP regulations and pharmaceutical quality systems.
• Demonstrated analytical, problem-solving, organizational, and communication skills.
• Ability to manage multiple priorities and collaborate effectively with cross-functional teams.
• Proficiency with Microsoft Office applications including Excel, Outlook, Word, and PowerPoint.
• Experience with systems such as TrackWise, SAP, Veeva, Documentum, QUMAS, ERP, or MES preferred.

Pay

Pay Rate: $40–45/hr

Schedule

Long-Term Contract Opportunity, Hybrid Schedule

Benefits

• Medical, Dental, Vision
• 401K
• PTO
• Sick Leave (as required by law)
• Paid Holidays