Qureos

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Senior Quality Assurance Specialist

Key Responsibilities

  • Review and approve quality documentation, including batch records, deviations, change controls, and validation-related documents
  • Partner with Manufacturing and Operations to support and/or lead deviation investigations, including root cause analysis and corrective actions
  • Maintain a strong QA presence on the manufacturing floor to ensure compliance and provide real-time support
  • Balance production timelines with quality requirements to support efficient operations
  • Perform material review and release activities for raw materials, components, and consumables
  • Support batch record review, product disposition, and overall release processes
  • Mentor and provide guidance to QA team members on shift
  • Make real-time quality decisions regarding deviations, product impact, and escalation needs
  • Contribute to deviation investigations, CAPA development, and risk assessments
  • Ensure adherence to SOPs, regulatory requirements, and site quality standards
  • Utilize electronic and paper-based systems (QMS, LIMS, etc.) to maintain data integrity
  • Analyze quality trends and identify sources of variability using data and statistical tools
  • Manage multiple priorities in a fast-paced GMP environment


Qualifications

  • Bachelor’s degree in a scientific discipline (or equivalent experience)
  • 8+ years of experience in a GMP-regulated manufacturing environment
  • 4+ years of direct QA oversight supporting manufacturing operations
  • Experience with quality systems, including deviations, CAPA, and change control
  • Strong understanding of GMP regulations and product disposition processes
  • Excellent written and verbal communication skills
  • Experience with data analysis tools and manufacturing systems is preferred

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