Clinical QA Specialist: GMP, Batch Release | Hybrid

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

Sick leave

Paid holidays

Hybrid schedule

Job summary

Piper Companies in Lansdale, PA seeks a Quality Assurance Specialist to ensure quality and compliance of clinical supply materials. You will oversee batch disposition, support release activities, and guide investigations within cGMP standards for global clinical studies.

Responsibilities include reviewing batch documentation, driving CAPAs, and collaborating with cross-functional teams on packaging, labeling, and distribution. Hybrid work and comprehensive benefits are offered.

Qualifications

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

Responsibilities

• Review and disposition clinical supply materials to ensure compliance.
• Perform batch documentation reviews and support release activities.
• Assist with quality investigations, deviations, CAPAs, and change control.
• Support quality process improvements and procedural updates.
• Collaborate with cross-functional teams on packaging, labeling, distribution, and supply chain.

Skills

Analytical

Problem-solving

Organizational

Communication

Cross-functional collaboration

Education

Bachelor’s degree in a scientific, engineering, or related technical field

Tools

TrackWise

SAP

Veeva

Documentum

QUMAS

ERP

MES

Job description

Piper Companies in Lansdale, PA seeks a Quality Assurance Specialist to ensure quality and compliance of clinical supply materials. You will oversee batch disposition, support release activities, and guide investigations within cGMP standards for global clinical studies.

Responsibilities include reviewing batch documentation, driving CAPAs, and collaborating with cross-functional teams on packaging, labeling, and distribution. Hybrid work and comprehensive benefits are offered.