R&D Quality Operations Specialist – Audit & Training

Planet Pharma; Princeton (NJ); Hybrid; USD 26,000 - 39,000; Full time

Job summary

Planet Pharma in Princeton, NJ seeks an Operations Quality Risk and Compliance assistant to support IR, process improvement and training within R&D quality efforts. You will collaborate with Quality Operations and internal R&D teams across Clinical Development, Regulatory Affairs and more.

You will help with inspection readiness, CAPA tracking, cross-functional coordination, and dashboards using Smartsheet and Power BI to monitor IR performance.

Qualifications

• Bachelor’s degree in Science or related field with minimum 2 years in pharma/biotech quality or R&D.
• Experience in Quality, Clinical Operations, Project Management or related R&D functions.

Responsibilities

• Audit and Inspection Readiness support and tracking IR actions.
• Assist with inspection preparation, minutes, trainings, and cross-functional inputs.
• Coordinate CAPAs and follow-up actions post-inspection.
• Support regulatory inspections as scribe and process requests.
• Develop dashboards and metrics (Smartsheet, Power BI) for IR activities.
• Support process improvement initiatives and project tracking.
• Assist with quality training materials and workshops.
• Prepare materials for QRC department meetings and metrics.

Education

Bachelor’s degree in Science or related field

Tools

Veeva Systems

Power BI

Smartsheet

Microsoft Word

PowerPoint

Excel

Job description

Planet Pharma in Princeton, NJ seeks an Operations Quality Risk and Compliance assistant to support IR, process improvement and training within R&D quality efforts. You will collaborate with Quality Operations and internal R&D teams across Clinical Development, Regulatory Affairs and more.

You will help with inspection readiness, CAPA tracking, cross-functional coordination, and dashboards using Smartsheet and Power BI to monitor IR performance.