Quality Assurance Manager

2 days ago


Houston, Texas, United States Sunrise Systems Full time

Job Title: QA Specialist III

Location: Remote

Duration: 6 Months with possibility of extension

Position Type: Hourly contract Position (W2 only)

Key Requirements:

  • Minimum 5 years' experience in a Quality Assurance role
  • Proven track record in a cGMP environment and related QA field
  • Strong background in KPI and/or KQI analysis and reporting
  • Experience with Track wise systems and data analysis
  • Proficient in Excel and data visualization tools

Key Responsibilities:

Lead Quality Council and Quality Management Systems Program:

  • Facilitate the implementation of client quality systems and compliance initiatives projects
  • Identify, maintain, and report site quality KPIs for Quality Council
  • Own and manage the site's Quality Council program, including hosting and ensuring participation of SMEs in monthly Quality Council meetings
  • Report site quality KPIs in client's KPI reporting system monthly
  • Identify actions required to meet site KPI targets and facilitate activities necessary to meet those targets
  • Support and host change controls review board, deviation review board, and CAPA review board
  • Responsible for site monthly and quarterly trending program and associated reports
  • Identify and facilitate 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


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