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Senior Quality Assurance Specialist

2 months ago

Houston, Texas, United States Sunrise Systems Full time

Position: Senior Quality Assurance Specialist

Location: Houston, TX

Contract Duration: 6 Months with potential for extension

Type: Hourly Contract Position (W2 only)

Essential Qualifications:

  • At least 5 years of relevant experience
  • Experience in a cGMP environment and related quality assurance fields
  • Proficiency in Key Performance Indicators (KPI) and/or Key Quality Indicators (KQI)
  • Familiarity with TrackWise software
  • Advanced skills in Microsoft Excel

Primary Responsibilities:

Oversee the Quality Council and Quality Management Systems program by:

  • Facilitating the execution of quality systems and compliance initiatives at the site
  • Identifying, tracking, and reporting site quality KPIs for the Quality Council
  • Taking ownership of the site's Quality Council program, including organizing and ensuring participation of Subject Matter Experts (SMEs) in monthly meetings
  • Reporting site quality KPIs in the client’s KPI reporting system on a monthly basis
  • Identifying necessary actions to achieve site KPI targets and collaborating with SMEs to implement those actions
  • Supporting and leading change control review boards, deviation review boards, and CAPA review boards
  • Managing the site’s monthly and quarterly trending program along with related reports
  • Identifying and facilitating the execution of Corrective and Preventive Actions (CAPAs) related to observed trends
  • Reviewing or approving quality documentation (change controls, deviations/investigations, CAPAs, and controlled documents such as SOPs and forms) related to compliance or risk management
  • Performing additional duties as assigned