Senior QA Engineer - Aseptic Fill/Finish & Compliance

Perspective Therapeutics, Inc.; Coralville (IA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading biopharmaceutical firm located in Iowa is seeking a Senior Quality Assurance Engineer to provide oversight for aseptic fill/finish manufacturing operations. The role requires a BS/BA degree in a scientific discipline and at least 7 years of experience in the pharmaceutical industry, with strong skills in quality oversight, problem-solving, and collaboration. Responsibilities include developing and approving validation protocols, conducting risk assessments, and ensuring compliance with regulatory standards.

Qualifications

• 7+ years in a GMP environment.
• 3+ years in quality assurance.
• Leadership abilities in quality assurance projects.

Responsibilities

• Provide Quality oversight for aseptic fill/finish manufacturing.
• Collaborate with teams to identify root cause of problems.
• Develop and approve qualification/validation protocols.

Skills

Collaboration

Problem-solving

Attention to detail

Communication

Quality oversight

Education

BS/BA in a scientific discipline

7+ years in pharmaceutical industry

Experience in quality assurance

Tools

Statistical analysis tools

Quality Management Systems

Job description

A leading biopharmaceutical firm located in Iowa is seeking a Senior Quality Assurance Engineer to provide oversight for aseptic fill/finish manufacturing operations. The role requires a BS/BA degree in a scientific discipline and at least 7 years of experience in the pharmaceutical industry, with strong skills in quality oversight, problem-solving, and collaboration. Responsibilities include developing and approving validation protocols, conducting risk assessments, and ensuring compliance with regulatory standards.