Quality Assurance Specialist

4 weeks ago


Houston, United States AdvantEdge Full time

Job Title: Quality Assurance Specialist ( Pharma )

Location: Houston, TX, 77047

Duration: 6 Months

Job Type: Contract

Work Type: Onsite

Pay rate : $45-$45.00 / hourly


Responsibilities:

  • Lead Quality Council and Quality Management Systems program
  • Facilitates the implementation of clients 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

Qualifications:

  • Key requirements: Minimum 5 years’ experience
  • cGMP environment and related QA field
  • Must have KPI and/or KQI experience
  • Must have Trackwise experience
  • Must be proficient in Excel



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