Demo

Snr Quality Specialist

Covance
Barre, MA Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/19/2025

Job Overview :

  • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
  • Ensure compliance of operations with governing regulatory requirements
  • Create, maintain and assume accountability for a culture of high customer service
  • Nurture and sustain an environment of continuous learning- Take ownership of assigned aspects of quality reviews on projects
  • Compile metrics and identify quality trends
  • Assist in addressing periodic client quality reviews and other ad-hoc client quality findings
  • Prepare initial drafts of Corrective and preventive actions
  • Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers
  • Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards
  • Contribute to designing and tracking training schedule and training material for new hires and existing team.
  • Help initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects.
  • Assist in coordinating respective client or external audits of the assigned projects.
  • Draft sections of the Quality Management Plan for assigned project
  • Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager

Education / Qualifications :

  • Bachelors / Masters degree in Medicine or Alternative medicine or Pharmaceutical science
  • Experience :

  • 3 plus years of overall work experience in the functional area with at least 1 years experience in Peer review / Quality review and experience in CAPAs and quality trending
  • Experience in generating quality metrics with trend analysis, authoring and coordinating Corrective and Preventive Action Reports
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