Senior Quality Assurance Technician

6 days ago


Concord NC, United States Lilly Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Technician to join our team at Lilly. As a key member of our Quality Assurance department, you will be responsible for providing QA oversight to GMP operations and supporting the start-up and qualification of our Concord site.

Key Responsibilities
  • Provide QA support for the start-up and qualification of the Concord site
  • Collaborate cross-functionally with various levels of the organization to demonstrate teamwork and support
  • Support and escalate issues from manufacturing to the site-based process team for one of the following manufacturing areas:
    • Formulation and Equipment Preparation Processes
    • Automated and Semi-automated Visual Inspection
    • Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area
  • Support creation of Standard Operating Procedures and associated Forms, Tools and Training
  • Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Trackwise and MES
  • Support the execution of inspection readiness activities including support of site self-inspections
  • Communicate any compliance issues associated with the project or site to Quality Management
  • Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations
Requirements
  • Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
  • Ability to work independently with minimal supervision
  • Proficiency with computer systems including Trackwise, MES, Microsoft Programs
  • Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
  • H-1B or TN status) for employment positions on the B paths or at R1 Level
  • Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
  • Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection
  • Previous technical writing experience
  • Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work)
  • Overtime and off-shift support may be required
What We Offer

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.



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