QA Specialist- 237273 Job at Medix™, Brownsburg, IN

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  • Medix™
  • Brownsburg, IN

Job Description

Company Overview

We are a fast-growing clinical-stage biotech company focused on targeted alpha therapy (TAT) for cancer treatment. With strong preclinical and clinical results, we are preparing for commercialization and seeking passionate employees to join our team.

Why Join Us?

  • Contribute to innovative cancer therapies.
  • Work in a high-performance, results-driven team.
  • Be part of a growing pharmaceutical company.

Position Summary

Seeking a Senior Specialist, Quality Assurance for a new sterile manufacturing facility for radiopharmaceuticals. This role involves establishing high-quality standards and ensuring compliance.

Key Responsibilities:

  • Draft/review QA documents, SOPs, and risk assessments.
  • Support technology transfer and vendor qualification.
  • Ensure batch release, document control, and material inspections.
  • Maintain QA presence in manufacturing and oversee GMP compliance.
  • Conduct audits, investigations, and CAPA coordination.
  • Lead QA initiatives and promote continuous improvement.

Qualifications:

  • 3+ years QA experience (2+ in pharma, 1+ in aseptic manufacturing).
  • Strong knowledge of GMP, cleanrooms, and regulatory compliance.
  • Bachelor’s in a scientific field preferred.
  • Excellent attention to detail, problem-solving, and leadership skills.

Join us and help revolutionize cancer treatment. Apply today!

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