Commissioning/Qualification Specialist

Job Post Index 25887E-Sy##
Location Devens, MA
Description: Job Description
  • Participate as part of a cross functional global project to qualify QC instruments and associated software
  • Create, execute, and review network-led QC instrument/software qualification documents in support of global QC projects
  • Support the implementation of a standardized global qualification for QC instrumentation and associated software across multiple QC sites
  • Author qualification related deviations, identifying root causes and robust CAPAs
  • Author qualification related change controls and validation plans
  • Update procedures and documents to implement data integrity controls arising from instrument qualification programs.
  • Serve as liaison with lab-IT teams to harmonize QC instrument’s software configurations where applicable
  • Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
  • Provide updates on qualification status, project timelines, and escalate challenges
  • Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team.
  • Support general QC asset management
  • Coordinate/interface with vendors for servicing/maintenance/upgrades
  • Execute periodic assessments/decommissioning
Skills: Qualifications
  • Bachelor’s degree in relevant scientific or computer area with 7 – 10 years’ experience in the biopharmaceutical industry; OR
  • MS degree with 6+ years’ experience or equivalent combination of education and experience.
  • Minimum 6 years’ experience in a role either (a) QC instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
  • Demonstrated expertise in large projects, prioritizing workload with minimal supervision
  • Demonstrated ability to work independently as well as contribute to a team based collaborative environment
  • Self-directed with a high degree of professional integrity, organization, and attention to detail.
  • Strong interpersonal, oral, and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
  • Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

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