Quality Assurance Specialist

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

PTO

Paid holidays

Hybrid schedule

Job summary

Piper Companies is seeking a Quality Assurance Specialist to join a leading pharmaceutical organization in Lansdale, PA. You will ensure quality and compliance of clinical supply materials through batch disposition activities, quality systems oversight, and cGMP adherence supporting worldwide studies.

The role requires 5+ years in a GMP-regulated environment, experience with batch disposition and investigations, and proficiency with TrackWise, SAP, Veeva, and related systems.

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.

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 our company’s production system (PS) tools within problem solving and daily activities.

Skills

GMP knowledge

Analytical skills

Problem solving

Cross-functional collaboration

Microsoft Excel

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 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 of the Quality Assurance Specialist:

• 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 our company’s production system (PS) tools within problem solving and daily activities.

Qualifications of the Quality Assurance Specialist:

• 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

Compensation for the Quality Assurance Specialist:

• Pay Rate: $40–45/hr.
• Long-Term Contract Opportunity, Hybrid Schedule
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave (as required by law), and Paid Holidays

Application Period:

This position opens for applications on 8/6/2026 and will remain open for a minimum of 30 days from the posting date.

Keywords:

Batch Disposition, Batch Release, Clinical Trial Application, Clinical Supply Quality, Clinical Supply Chain, GMP, cGMP, Quality Assurance, CAPA, Deviation Management, Investigation Management, Clinical Trial Materials, Regulatory Compliance, IND, CTA, Clinical Packaging, Clinical Labeling, Root Cause Analysis, Change Control, Lean Six Sigma, TrackWise, SAP, Veeva, Pharmaceutical Manufacturing, Quality Systems, Continuous Improvement

#LI-CK1 #LI-HYBRID