Demo

Quality Complaints Specialist 1

Katalyst Healthcares & Life Sciences
Sumter, SC Full Time
POSTED ON 1/31/2025
AVAILABLE BEFORE 3/30/2025
Responsibilities:
  • Evaluates customer complaints, including the coordination of documentation review, sample testing, and root cause analysis.
  • Leads and/or facilitates the compliant investigation to reduce or eliminate causes of the complaints.
  • Analyzes complaint data and reports trends and triggers for significant complaint issues.
  • Trends complaint data to identify significant changes and identifies chronic complaint categories.
  • Documents all activities related to complaint analysis, failure investigation, corrective action, preventive action, and efficiency.
  • Maintains customer complaint related files per policy/procedures.
  • Handles returned samples in a safe manner, taking all vital precautions related to contaminated and 'sharp' products.
  • Audits corrective actions implemented to remedy complaints for efficiency.
  • Ensures compliance with Federal Regulations and International Standards where appropriate.
  • Performs dimensional inspections for all departments as needed.
  • Provide Continues Improvement solutions to their process, department or the facility.
  • Performs miscellaneous duties as required.

Requirements:

  • Bachelor of Science preferred but experience would be considered
  • Must have experience answering customer complaints to include review of Batch records and determination of root cause for complaint issue
  • Must have adequate written skills to write summary of investigation.
  • Experience in software program Trackwise would be a plus.

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