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Quality Assurance Senior Associate

West Greenwich, RI
Top 3 Must Have Skill Sets
  • Experience with SM LIMS (data reporting management system, laboratory information system)
  • Experience with system validation, specifically SM LIMS (system validation)
  • Quality Assurance oversight and record management, specifically deviations, corrective/preventive actions and effectiveness verifications (ownership of documentation, data entry verification)

Soft Skills
  • Project management
  • Proficiency in Excel, Word, and Power Point
  • Strong interpersonal skills

  • Job Details: Will assist with document review and initiate incidents, as well as coordinate and compile general documents and oversee room clearance inspection.; Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry
  • Responsible for SM LIMS data coordination activities, including sample reconciliation and CoA generation.
  • Responsible for management of SM LIMS approval based tasks; aligned to source documentation.
  • Responsible for supporting validation activities for SM LIMS and associated quality document management.
  • Responsible for data queries from QC’s electronic systems.
  • Responsible for QC Assessor for Change Controls impacting analytical systems.
  • Provides ownership and QA oversight for document management of various processes within QC.
  • Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
  • Supports inspection readiness activities across Quality Control, and site audits and inspections.
  • Maintains project plan commitments supporting critical projects
  • Supports Continual Improvement initiatives, programs and projects. 

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Sr Associate

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