Aseptic QA Engineer: GMP Quality & Compliance

Perspective Therapeutics, Inc.; Coralville (IA); On-site; USD 70,000 - 110,000; Full time

Job summary

Perspective Therapeutics, Inc. seeks a Quality Assurance Engineer to provide QA oversight for aseptic fill/finish manufacturing, ensuring CGMP compliance for products and materials.

The role entails coordinating with manufacturing, facilities, QA/QC, and supply chain, performing batch issuance and investigations, and developing qualification/validation documentation to support regulatory submissions.

Qualifications

• BS/BA in a scientific discipline with 3-5+ years in pharma/GMP environment.
• 1-2+ years of QA and qualification/validation within a regulated industry.
• Aseptic fill-finish experience with qualification/validation knowledge.

Responsibilities

• Collaborate across teams to identify root causes and corrective actions.
• Perform batch issuance, review and release of clinical drug products.
• Develop, review and approve qualification/validation protocols and reports.
• Contribute to risk assessments and implement mitigation strategies.
• Lead change controls and QA surveillance activities when needed.

Skills

GMP/GxP

Investigations

CAPA

Quality systems

Education

BS/BA in science

Pharma experience

Job description

Perspective Therapeutics, Inc. seeks a Quality Assurance Engineer to provide QA oversight for aseptic fill/finish manufacturing, ensuring CGMP compliance for products and materials.

The role entails coordinating with manufacturing, facilities, QA/QC, and supply chain, performing batch issuance and investigations, and developing qualification/validation documentation to support regulatory submissions.