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Quality Assurance Technician I

2 months ago

Bloomington, Indiana, United States Greiner Full time

Your Challenge

As a Quality Control Operator I, you will play a crucial role in ensuring the integrity of our products. Your responsibilities will include:

  • Conducting quality control testing and assessments in accordance with established protocols.
  • Performing inspections on incoming goods to verify compliance with specifications.
  • Preparing necessary solutions and equipment for production in line with technical procedures and standard operating procedures.
  • Maintaining cleanliness and sanitation in laboratory and quality control areas.
  • Executing quality inspections on the manufacturing floor to uphold product standards.
  • Issuing Quality Incident Reports (QIR) for any non-conforming products.
  • Testing non-conforming products to address QIR issues and investigating returned items through the complaint processing system.
  • Carrying out equipment calibration to ensure accuracy.
  • Conducting routine inventory checks for laboratory supplies and chemicals.
  • Assisting in the maintenance of the inventory database and SAP inventory management.
  • Supporting the ordering process for chemicals and laboratory supplies.
  • Performing additional duties as assigned.

Your Authority

In this role, you will have the authority to:

  • Evaluate products during production based on quality management documents.
  • Restrict non-conforming products in accordance with relevant quality management documentation.
  • Authorize the release of products following valid quality management protocols.
  • Approve incoming goods based on Certificates of Analysis.
  • Authorize sterilization processes.
  • Release solutions as per established guidelines.
  • Execute SAP transactions for holding and releasing products.

Your Profile

To be successful in this position, you should meet the following requirements:

  • A high school diploma or equivalent; a degree is preferred along with at least one year of relevant experience.
  • Experience in the medical device, pharmaceutical, or regulated industries is advantageous.
  • Strong communication and writing skills are essential.
  • Completion of a quality control training program for a minimum of three months is required.
  • Passing a pre-employment assessment is necessary.
  • Basic computer skills and proficiency in MS Office are expected.

Physical Requirements

The role requires:

  • The ability to stand and walk for extended periods, up to 8-12 hours.
  • The capability to lift items weighing up to 70 lbs.
  • Appropriate vision to conduct detailed quality inspections as specified in standard operating procedures and technical procedures.