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Sr. Quality Engineer

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Sr. Quality Engineer

Nanjing, China

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Manage and improve pre and post review and approval process of production batch records.
• Manage and improve the process of QA release of finished products in GPMS.
• Management of Deviation/Complaint and CAPA system as per FCS procedure. Review and approve the problem report as the QA representative.
• Take the administrator of TrackWise system, and responsible for system users management and initial training.
• Manage and improve site document control process, and responsible for Documentum system users management and initial training.
• Management of self-inspection programme. Arrange and coordinate the implementation of self-inspection and follow up the completion of actions timely. Perform self-inspection as qualified internal auditor and routine data integrity compliance check.

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• Manage and monitor GxP related change to ensure that can identify the potential risk and take the mitigation action.
• Manage and improve the process of new and existing suppliers assessments and keep the Approved Supplier List updated.
• Maintain cold chain management, including shipper qualification report review, approved shipper box list update.
• Monitor facility environment condition, including calibration/maintenance/Pest Control activities verification and Business continuity planning program management and etc..
• Management of validation/qualification system. Review and approve validation protocol and report as the QA representative.
• Assist QA Manager in regulatory and client audits. Follow up the implementation of audit response and actions for audit finding.
• Coordinate Recall event and organize annul mock recall activity, prepare all required documents and records.
• Perform and support Incoming Inspection / Approval on Receiving and Returns.
• Perform and support packaging inspection and checks (including Computerized Label Inspection if applicable).
• Perform ad-hoc duties as requested by line management.

Client-provided location(s): Jiangsu, China
Job ID: ThermoFisher-R-01295792
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program