Quality Assurance Floor Support Specialist

3 days ago

Concord, New Hampshire, United States BioSpace, Inc. Full time
Job Details

At Lilly, we are committed to delivering innovative medicines to patients around the world. We are seeking a Quality Assurance Floor Support Specialist to provide QA oversight to GMP operations at our new Concord site.

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.
  • Support project initiatives needed for the project and Quality function.
  • 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 & accountable for supporting all HSE Corporate, Project, and Site Goals.
  • Ability to work a 12-hour night shifts 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.
Education Requirements:
  • High School diploma or equivalent.
Additional Skills/Preferences:
  • Associate's 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, device assembly, packaging, utilities, facilities, maintenance, and warehouse management.
  • Previous experience with Manufacturing Execution Systems.
  • Previous technical writing experience.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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