The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN
Job Summary
The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN.
This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations.
Our benefits include Health Coverage, Wellbeing Support, Financial Well-being and Protection, and Work-life benefits.
Matching Summary
The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN.
Salary
Base: $82,236 - $99,650; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
GMP compliance
Quality Assurance Operations
Material and batch disposition
Deviation and CAPA review
cGMP regulations knowledge
Nice-to-have
Cross-functional relationship building
AI tools for productivity
Audit and inspection response
Problem-solving and decision-making
Key Requirements
Minimum of 5 years’ experience in QA/compliance
BS/MS degree in science related field preferred
Experience in GMP aseptic manufacturing preferred
Experience with FDA or other regulatory authorities preferred
Knowledge of US, EU and rest-of-world cGMP regulations