QA Specialist III

Sunrise Systems
Edison, NJ

Job Title: QA Specialist III

Location: Houston, TX 77047

Duration: 6 Months with possibility of extension

Position Type: Hourly contract Position (W2 only)

Key requirements:

  • Minimum 5 years' experience
  • cGMP environment and related QA field
  • Must have KPI and/or KQI experience
  • Must have Track wise experience
  • Must be proficient in Excel

Key responsibilities:

Lead Quality Council and Quality Management Systems program by:

  • Facilitates the implementation of client quality systems and compliance initiatives projects at the site
  • Identifies, maintains and reports site quality KPIs for Quality Council
  • Responsible for ownership of the site's Quality Council program, including hosting and ensuring participation of SMEs in monthly Quality Council meetings
  • Reports site quality KPIs in client's KPI reporting system monthly
  • Identifies actions required to meet site KPI targets and facilitates with SMEs activities necessary to meet those targets
  • Supports and hosts change controls review board, deviation review board and CAPA review board.
  • Responsible for site monthly and quarterly trending program and associated reports
  • Identifies and facilitates execution of CAPAs related to identified trends
  • Revise or approve quality records (change controls, deviations/ investigations, CAPAs and controlled documents-SOPs, forms, etc., related to compliance or risk management program.
  • Perform other duties as assigned

Posted 2025-11-26

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