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Position Brand Description: The Quality Assurance Associate is responsible for quality compliance and oversight within manufacturing operations. Position will provide assistance and guidance on day-to-day compliance, process documentation, investigations, change controls, quality training, review and approval of process documents and to ensure adherence to regulatory guidelines and Elanco Quality standards.   The QA Associate works as a team member within the process teams to achieve site goals while maintaining a strong quality culture.

Key Objectives/Deliverables

  • Provide a daily presence within manufacturing to ensure Safety, Quality and Supply goals are met.
  • Ensure contemporaneous batch record review, provide quality guidance, and provide training on fundamental quality guidelines.
  • Responsible for review and approval of quality documents, including but not limited to SOPs, forms, protocols.
  • Complete or assist with batch disposition of incoming materials, semi-finished (antigen), and finished materials (vaccine)
  • Participate in internal/external regulatory inspections
  • Assess non-conformances that occur against the site standard procedures, manufacturing production records, regulatory guidelines and Elanco standards.
  • Function as a quality partner, providing guidance to colleagues writing change controls and/or completing investigations; responsible to ensure deviations and change controls meet site and Elanco standards
  • Mentor and coach site personnel on quality
  • Maintain a general working knowledge of manufacturing process in the process team functional area
  • Other duties as assigned

Minimum Qualification (education, experience and/or training, required certifications):

  • B.S. Degree or equivalent Microbiology/Biology/Chemistry/Engineering (Science or Engineering related degree preferred).
  • Experience working within a team; strong interpersonal and team building skills; ability to lead and influence in a team environment
  • Root cause analysis and troubleshooting skills
  • Technical writing skills
  • Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
  • Must not have contact with avian species (birds) at home due to the nature of the manufacturing

Additional Preferences:

  • Experience working within the quality systems in an FDA or USDA regulated aseptic manufacturing facility
  • Excellent communication and organization skills
  • Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
  • History and experience with continuous improvement (LEAN, Six Sigma, etc.)

Other Information:

  • Off hours and weekend work may be required
  • Potential exposure to chemicals, allergens, and loud noises
  • Personal Protective Equipment (PPE) and clean room environment may apply

Elanco 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