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Quality Assurance (QA) Specialist I
Spectraforce
North Chicago, Illinois

2 hours ago

Job Description

Position Title: Quality Assurance (QA) Specialist
Work Location: North Chicago, Illinois, 60064
Assignment Duration: 6 Month
Work Arrangement: 100% Onsite

Position Summary: The Quality Assurance (QA) Specialist I is responsible for product complaint documentation, investigations, identification of product defects and/or damage, and summarizing investigational data into a complaint handling system. Individual uses expertise and a thorough thought process to determine next step in testing.

Key Responsibilities:

  • Perform product complaint documentation, investigation, and review of all non-medical complaint content. Analyze and test routine to medium complexity products, and evaluate results
  • Performs test methods as written to support product complaint investigation activities.
  • Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP.
  • This requires good analytical skills, technical writing, and good documentation
  • Responsible for complaint data meeting all regulatory requirements.
  • Identification and initiation of appropriate exception documents in accordance with procedural requirements; supports the investigation process
  • Supports redline changes to local documents; Supports team to meet broader business objectives; Assists in projects and activities
  • Budgets their time with minimal supervision to effectively carry out assigned tasks and proposes improvements to processes across the QA lab.
  • Takes initiative to be a key player in team activities.
  • Understands, implements, and maintains a safe work environment and good manufacturing practices with respect to procedural requirements and laboratory records and requirements
  • Maintains lab for safety and compliance.
  • Maintains training certificates as needed for assigned job tasks.
  • Interprets data results for conformance with expected results as defined per procedures
  • Understands laboratory techniques and principles performed and can independently troubleshoot and resolve analytical techniques and instrument issues.
  • Understands, implements and maintains GxP with respect to laboratory records, procedures and systems in accordance with procedural requirements

Qualification & Experience:

  • Bachelor’s degree in science or technology
  • Lab Experience; Device background preferred
  • Agile; Can effectively manage time and handle multiple tasks
  • Solid written/ verbal communication skills and interpersonal skills
  • Critical thinking skills
 
Applicant Notices & Disclaimers
  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 25.00/daily.

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