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Quality Assurance Specialist

Spectraforce Technologies
United States, Illinois, North Chicago
Nov 08, 2024
Title: QA Specialist I

Duration: 1 year

Location/Site: North Chicago, IL

Purpose:

  • Perform sampling, inspecting, and physical testing of incoming commodities per appropriate product specifications in a laboratory.
  • Environment. Applies scientific knowledge to daily operations, data management, and problem-solving.
  • Understands and Follows documentation. Analyzes basic/simple data, evaluates results, forms conclusions, and recommends Process and document improvements.
  • Recognizes deviation from normal operating procedures.
  • Recognizes And troubleshoots instrumentation and work order problems and routine operational issues.



Responsibilities:

  • Responsible for performing routine testing on incoming materials by approved specifications and procedures.
  • Disposition of incoming material for use in manufacturing.
  • Maintains certification in assigned job responsibilities and completes training on time.
  • Participates in complaint handling, failure investigations, and CAPA documentation.
  • Understands, implements, and maintains the quality policy and ensures compliance with level policies and Procedures.
  • Develops knowledge of products and technologies.
  • Interacts on a necessary basis with internal and external
  • Support groups to perform core skills.
  • Participates in team activities and area metric tracking.
  • Responsible for supporting Operations efforts in meeting established production schedules.
  • Reports problems in a timely and accurate manner.
  • Seeks additional guidance or advice when the problem is beyond the scope of training or knowledge.



Qualifications:

  • High School Diploma required, Bachelor's degree preferred.
  • Good understanding of basic math.
  • Good clerical skills are required.
  • 4+ years of overall work experience
  • Computer skills proficiency including word processing, spreadsheets, instrumentation related, and Client Network systems.
  • Previous experience in Quality Assurance 2+ Experience in a manufacturing/finishing environment is desired.

    Previous knowledge of GMP regulations and standards affecting pharmaceutical products is desired.
  • Have an understanding of material/product traceability and Device History Records.

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