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Quality Validation Engineer

Company: Kelly Services
Location: Cambridge
Posted on: September 22, 2022

Job Description:

Quality Validation Engineer - Cambridge, MAFull-time, Contract position - 12+ monthsPay - $60-$70/hrShift Hours: 8-5pm 100% onsite Key Objectives of the role:

  • Supports the manufacturing process owners and other functional area managers as a Quality Assurance Validation subject matter expert.
  • Provides Quality support for complex cross-functional investigations in a variety of subject matter area to determine root cause and corrective actions.
  • Develops improvements to the Quality Management System to enhance compliance with regulatory requirements.
  • QA oversight for investigations to deviations and non-conformances identifying root cause, corrective/preventive actions, and effectiveness of actions taken.
  • Reviews and approves quality records, validation protocols, standard operating procedures, Work Orders, Preventative Maintenance activities, Calibration activities, changes to procedures and processes to ensure compliance with required standards.
  • Contributes expert process knowledge for product and process design and validation teams.
  • Works directly with customers (internal, external, suppliers) on complex critical to quality issues.
  • Quality oversight for cross-functional team projects (R&D, Mfg, Vendors, etc).

    Minimum Qualifications (must have):
  • Bachelor's degree in engineering or Science Discipline with minimum 5 years of experience or High School Diploma with 8 years of experience within the Pharmaceutical Industry supporting the manufacture of Regulated Product.
  • Advanced knowledge of Quality Engineering principles and practices in a FDA Regulated Environment.
  • Proficient in team building and leading product quality investigations.
  • Technical report documentation and authoring procedures.
  • Analytical Instrument Validation,
  • Analytical Method Validation,
  • Process Validation #P2

Keywords: Kelly Services, Cambridge , Quality Validation Engineer, Engineering , Cambridge, Massachusetts

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