Quality Technician, Portage Facility Operations

4 days ago


Portage, Indiana, United States Ursitti Enterprises LLC Full time

Job Description

The Advanced Quality Technician, Manufacturing Quality Assurance role at Ursitti Enterprises LLC is a challenging opportunity for a highly skilled professional to join our team at the Portage Facility. This role involves working closely with operations to develop, implement, and maintain quality systems that support manufacturing operations.

Key Responsibilities:

  • Liaises with operations to develop, implement, and maintain quality systems that support manufacturing operations.
  • Ensures adherence to GMP regulations throughout the manufacturing space.
  • Conducts AQL testing on finished products, verifying attributes such as product appearance, dimensions, and seal integrity.
  • Performs line clearances for all manufacturing process steps.
  • Reviews and assesses documentation, ensuring completeness and accuracy, and assists in obtaining corrections as needed.
  • Archives pest control documents and conducts QA retain sampling, analyzing and documenting results.
  • Spots checks and performs facility walkthroughs to ensure adherence to policies, procedures, and regulations.
  • Initiates event reports for incident resolutions and troubleshoots observed incidents.
  • Understands manufacturing schedules and provides quality support to ensure business continuity.

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: $70,000 - $90,000 per annum.


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