Manufacturing Quality Assurance Lead, Pharmaceutical Industry

2 weeks ago


Portage, Indiana, United States Ursitti Enterprises LLC Full time

About the Role

We are seeking a highly motivated Quality Technician, Portage Facility Operations to join our team at Ursitti Enterprises LLC. As a key member of our manufacturing team, you will play a crucial role in ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities:

  • Develops and implements quality systems that support manufacturing operations, meeting product and process quality metrics.
  • Provides GMP/GDP guidance to ensure proper actions and documentation occur within the manufacturing space.
  • Performs product sampling and testing to support drug product manufacturing, troubleshoots quality issues, and issues line-clearances.
  • Assists with problem-solving and investigation of nonconformances, real-time and post-manufacturing document reviews, and coordinates workflows and events.
  • Partners with operations to lead in developing, implementing, and maintaining quality systems.

Requirements:

  • Bachelor's degree in chemistry, biochemistry, or a related science field is preferred.
  • At least 3 years of experience in the pharmaceutical industry with increasing responsibility is desired.
  • Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements.
  • Technical proficiency in reviewing production records, reports, and GMP-related documentation.
  • Able to work within a team environment and contribute to company goals.
  • Strong technical writing skills and good problem-solving techniques.

Estimated Salary: $60,000 - $80,000 per annum.



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