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Quality Assurance Floor Support Specialist

1 month ago

Concord, New Hampshire, United States Eli Lilly Full time
Job Summary

We are seeking a Quality Assurance Floor Support Specialist to provide QA oversight to GMP operations at our Concord site. The successful candidate will support the startup, commissioning, and qualification of the site, and provide QA support for one of the following manufacturing areas: formulation and parenteral manufacturing, device assembly and packaging manufacturing, or warehouse logistics.

Key Responsibilities
  • Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area.
  • Follow good documentation practices and compliance with site procedures.
  • Review and approve GMP documentation such as electronic batch records, logbooks, etc.
  • Troubleshoot and provide support to resolve issues in quality systems such as SAP, LIMS, Trackwise, MES.
  • Maintain open communications and promote teamwork in the process team.
  • Support the execution of inspection readiness activities including support of site self-inspections.
  • Communicate any compliance issues to the project, site, and Quality Management.
Requirements
  • Knowledge of cGMP practices including good documentation practices, data integrity, and regulatory compliance.
  • Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
  • Strong attention to detail.
  • Ability to work independently with minimal supervision.
  • Proficiency with computer systems including Trackwise, SAP, etc.
  • Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate, Project, and Site Goals.
  • Ability to work a 12-hour night shift onsite on a rotating 2-2-3 schedule (not eligible for remote work).
  • Ability to work overtime as required.
  • Must pass an annual vision test.
  • Qualified candidates must be legally authorized to be employed in the United States.
Preferred Qualifications
  • Associate's degree in a science, engineering, computer, or pharmaceutical-related field of study.
  • Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management.
  • Previous experience with Manufacturing Execution Systems.
  • Previous technical writing experience.