On-Site Quality Operations Associate - Pharma GMP

Clinigen Group; Malvern (Chester County); On-site; USD 52,000 - 68,000; Full time

Job summary

Clinigen is seeking a QA inspector to ensure compliance with quality systems through inspection of incoming clinical supplies, trial labels, and in-process materials. This on-site role requires collaboration with operations and other departments to identify and resolve issues and to follow SOPs and GDP/cGMP practices.

The candidate will perform routine inspections, prepare necessary documents, and maintain compliance with established quality procedures to support reliable clinical supply chains.

Qualifications

• Partner with operations to identify and correct problems.
• Detail oriented and self-motivated with initiative.
• Excellent time management and ability to meet deadlines.

Responsibilities

• Perform routine cGMP inspections and disposition of clinical trial labels and materials.
• Prepare documents for use in cGMP activities.
• Complete in-process inspections to ensure product quality and compliance.
• Work with other departments to identify, investigate and resolve issues.
• Communicate operational concerns and opportunities for improvement to leadership.
• Know, understand and comply with SOPs and company policies.

Skills

High School Diploma or GED

Associate's Degree or 2 years' equiv. 

Education

High School Diploma or GED

Associate's Degree or 2 years' equivalent work experience

Job description

Clinigen is seeking a QA inspector to ensure compliance with quality systems through inspection of incoming clinical supplies, trial labels, and in-process materials. This on-site role requires collaboration with operations and other departments to identify and resolve issues and to follow SOPs and GDP/cGMP practices.

The candidate will perform routine inspections, prepare necessary documents, and maintain compliance with established quality procedures to support reliable clinical supply chains.