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Senior Quality Assurance Engineer at Perspective Therapeutics - ApplyBlast

Senior Quality Assurance Engineer

Perspective Therapeutics

4 months ago

Coralville, IA

Hybrid

Full Time

Senior

0 applicants

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About this role

The Senior Quality Assurance Engineer provides technical oversight and compliance expertise for an aseptic fill/finish manufacturing suite, ensuring adherence to CGMP regulations and company guidelines. The role involves leading root cause investigations, developing validation protocols, and managing risk assessments across manufacturing operations. This position requires collaboration with multidisciplinary teams to resolve quality issues, update SOPs, and maintain accurate documentation for regulatory submissions.

Responsibilities

Lead root cause investigations and determine appropriate corrective actions
Develop and approve qualification validation protocols for facilities and processes
Conduct risk assessments to identify potential quality and compliance issues
Create and update Standard Operating Procedures to ensure CGMP compliance
Represent Quality in Change Control Board meetings and multidisciplinary teams

Skills

Qualifications

BS or BA in a scientific discipline7+ years in pharmaceutical or radiopharmaceutical industry3+ years in quality assurance and qualification validation