Quality Engineer (CAPA/ Documentation)

Full Time
North Chicago, IL 60064
Posted
Job description

Purpose:

  • Perform sampling, inspecting, and physical testing of incoming commodities per appropriate product specification 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/or document improvements.
  • Recognizes deviation from normal operating procedures.
  • Recognizes and troubleshoots instrumentation and/or work order problems and routine operational issues.

Responsibilities :

  • Responsible for performing routine testing on incoming materials in accordance with approved specifications and procedures.
  • Disposition 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 to site 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 schedule.
  • Reports problems in a timely and accurate manner.
  • Seeks additional guidance or advice when problem is beyond scope of training or knowledge.

Qualifications :

  • High School Diploma required; Bachelor’s degree preferred.
  • Good understanding of basic math.
  • Good clerical skills is 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

Job Type: Contract

Salary: $32.46 - $35.00 per hour

Benefits:

  • Health insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • North Chicago, IL 60064: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Preferred)

Experience:

  • Quality engineer: 2 years (Preferred)
  • CAPA: 2 years (Preferred)
  • quality documentation: 2 years (Preferred)
  • pharma or medical device industry: 2 years (Preferred)

Work Location: One location

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