Senior Quality Associate, Sterility Assurance Specialist

3 days ago

Fort Dodge, Iowa, United States Elanco Animal Health Incorporated Full time
About Elanco Animal Health Incorporated

We are a global leader in animal health, dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is to advance the health of animals, people, the planet, and our enterprise.

Job Summary

We are seeking a Senior Quality Associate, Sterility Assurance to provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables of the manufacturing operations in the Biotech network. The successful candidate will work cross-functionally to improve site Sterility Assurance related processes and programs.

Key Responsibilities
  • Provide technical expertise in contamination control, aseptic processing, and sterilization, ensuring adherence to regulatory requirements and industry best practices.
  • Lead and oversee the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance.
  • Identify and troubleshoot issues related to sterility assurance, conduct root cause analyses, and implement corrective actions.
  • Develop and deliver comprehensive training programs for operators, technicians, and other relevant personnel on sterility assurance principles and best practices.
  • Ensure compliance with all applicable regulations and industry standards, prepare for and support regulatory inspections, and act as a subject matter expert during audits.
Requirements
  • Bachelor's degree in a related field (Microbiology, Biology, etc.) or equivalent experience in lieu of degree.
  • 3+ years' experience with sterile manufacturing.
  • Familiarity with Global Regulatory Standards FDA, EU GMP, USDA, CFIA, as applicable.
  • Experience with a variety of technologies and platforms is preferred, including poultry vaccine technologies, recombinant protein platforms, protein-based therapeutics, cell culture, and fermentation technology.
Preferred Qualifications
  • Experience with upstream production of viruses in cell monolayers, bioreactors, and fermenters or experience with biologicals manufacturing and aseptic manufacturing.
  • Lean manufacturing and six sigma experience.
  • Proven organization and time management skills to meet time-sensitive deadlines, attention to detail, and collaboration in a team-based environment.
  • Ability to work in a fast-paced and dynamic environment with changing priorities and flexibility to support multiple projects simultaneously.
Elanco Benefits and Perks
  • Multiple relocation packages for eligible roles.
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO).
  • 8-week parental leave.
  • 9 Employee Resource Groups.
  • Annual bonus offering.
  • Up to 6% 401K matching.

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