Quality Assurance Specialist - 174010

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

Benefits offered by this job

Medical, Dental, Vision

401K

Paid Holidays

Job summary

Piper Companies in the Greater Philadelphia area is seeking a Quality Assurance Specialist to ensure quality and compliance of clinical supply materials through batch disposition activities, system oversight, and adherence to cGMP standards for worldwide studies.

You will review batch documentation, support releases for clinical materials, and drive CAPA investigations, change controls, and continuous improvement initiatives across packaging, labeling, and supply chain utilities.

Qualifications

• Bachelor’s degree in a scientific, engineering, or related technical field.
• 5+ years in a GMP-regulated pharmaceutical/biotech industry.
• Experience with batch disposition/release or clinical material review.
• Knowledge of deviations, CAPAs, and change controls.
• Strong cGMP knowledge and QA systems.

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

Batch disposition

Quality assurance

Regulatory compliance

Analytical skills

Cross-functional teamwork

Problem solving

Communication skills

Microsoft Office

Education

Bachelor’s degree in a scientific, engineering, or related technical 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 located in the Greater Philadelphia area. 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 09/22/2026 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