cGMP Operations & Clinical Programs Specialist

University of Pennsylvania; Philadelphia (Philadelphia County); On-site; USD 62,000 - 70,000; Full time

Job summary

The University of Pennsylvania in Philadelphia seeks a cGMP Operations Specialist to provide operational, administrative, and project support to the CVPF and HIC, handling scheduling, calendaring, billing, data management, and documentation in a highly regulated cGMP environment.

You will coordinate with Operations, Manufacturing, Quality, and Clinical Operations while maintaining confidentiality and accuracy, ensure regulatory compliance with HIPAA, FDA guidance, FACT accreditation, and

Qualifications

• BS degree and 3–5 years of related GMP/operations experience.
• Experience with data analysis in a regulated environment is preferred.
• Strong communication and cross-functional collaboration skills.
• Detail-oriented with excellent organization and time management.

Responsibilities

• Coordinate day-to-day cGMP manufacturing scheduling and VP project templates.
• Coordinate donor activities, regulatory requirements, and IRB communications.
• Provide grant and administrative support, including meeting logistics and reporting.
• Maintain Excel-based trackers for clinical trial status and manufacturing data.

Skills

Data analysis

Scheduling

Communication

Multitasking

Time management

Education

Bachelor of Science

Tools

Microsoft Word

Excel

PowerPoint

Job description

The University of Pennsylvania in Philadelphia seeks a cGMP Operations Specialist to provide operational, administrative, and project support to the CVPF and HIC, handling scheduling, calendaring, billing, data management, and documentation in a highly regulated cGMP environment.

You will coordinate with Operations, Manufacturing, Quality, and Clinical Operations while maintaining confidentiality and accuracy, ensure regulatory compliance with HIPAA, FDA guidance, FACT accreditation, and