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Quality Assurance Coordinator

Quality Assurance Coordinator

GC AmericaAlsip, Illinois, United States
4 days ago
Job type
  • Full-time
Job description

ESSENTIAL DUTIES and RESPONSIBILITIES :

  • Approve batches for release
  • Inspect production records (batch records, bar code labels, inspection sheets) and visually confirm a sample for each finished good.
  • Ensure compliance with all established procedures and quality requirements, investigate and resolve discrepancies.
  • Track non-standard batch numbers (e.g., multiple batch pairings and / or kit component updates) to assure conformance with batch pairing and / or kit component procedures.
  • Support the document control process throughout the different cycle.
  • Drive the execution of daily management for related QMS processes, taking required action to investigate trouble reports and implement improvements.
  • Support the assignment and verification of trouble reports to responsible associates based on issues occurring within related QMS process.
  • Support process trouble / CAPA investigations activities, as needed.
  • Support the nonconformity process activities, as needed.
  • Support the complaint process activities, as needed.
  • Prepare standard reports and KPI data and submit to peers and / or superiors according to planned arrangements.
  • Prepare and submit data and related evidence for QMS Management Reviews.
  • Participate in external audits (ISO, FDA, etc) as a subject matter expert for related QMS processes, as needed.
  • Manage the response to audit items fromher response formance of designated Quality Assurance process activities :
  • non-conformities for related QMS processes, as needed.
  • Provide Quality Management System training to operations and other departments, as needed.
  • Participate in GQM improvement activities including high priority KI projects, as needed.

MINIMUM QUALIFICATIONS :

  • 3+ years of experience in a regulated industry (Med Device, Food, Drug, etc)
  • Demonstrated understanding of Quality Management System requirements (ISO, FDA, GMP, etc)
  • Working knowledge and understanding in the use of standard work / SOPs.
  • Skills with QC tools & techniques is preferred but not required (Control Charts, Histograms, Pareto diagrams, Cause & Effect diagrams, Process Flow Diagrams, Check sheets, Scatter Diagrams, etc.)
  • The ability to communicate with peers in operations to share information, hold nonconforming items, engage on problem-solving activities.
  • Experienced in technical report writing and analytical skills
  • Skilled in Microsoft 365 tools and technology

    • Education : BA / BS Degree in science, engineering or related field is preferred. Equivalent experience in Quality related or adjacent role will be considered.

    Experience and / or Training : 3+ years of related Quality Management System experience. Quality certification (ASQ, etc.) is a plus.

    Benefits :

  • 401(k) through Fidelity and company matching up to 10%
  • Dental insurance with Delta Dental PPO
  • Health insurance BCBS Illinois PPO
  • Employee assistance program
  • Health savings account
  • Company Paid Life Insurance two times the annual salary
  • Paid time off, including an extra paid week off the week between Christmas and New Year
  • Tuition reimbursement
  • Vision insurance EyeMed
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    Quality Assurance Coordinator • Alsip, Illinois, United States