Quality Assurance Specialist - 174010

ZP Group; Philadelphia (Philadelphia County); Hybrid; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401K

Paid Time Off

Paid 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 ensuring quality and compliance of clinical supply materials through batch disposition activities, quality systems oversight, and adherence to cGMP standards supporting worldwide clinical studies.

The ideal candidate has 5+ years in a GMP-regulated environment, experience with batch disposition or release, and strong analytical, communication, and

Qualifications

• Bachelor’s degree in a scientific, engineering, or related technical field preferred.
• 5+ years of GMP-regulated pharma/biotech experience.
• Experience with batch disposition, batch release, or clinical material review preferred.
• Knowledge of investigations, deviations, CAPAs, and change controls.
• Strong knowledge of cGMP and pharmaceutical quality systems.
• Analytical, problem-solving, organizational, and communication skills.
• Ability to manage multiple priorities with cross-functional teams.
• Proficiency in Microsoft Office applications (Excel, Outlook, Word, PowerPoint).
• Experience with TrackWise, SAP, Veeva, Documentum, QUMAS, ERP, or MES preferred.

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 compliance

Analytical thinking

Cross-functional collaboration

Documentation review

Quality system knowledge

Education

Bachelor's degree in a scientific 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