Senior Quality Assurance Specialist

5 days ago

Fort Dodge, Iowa, United States Elanco Full time

About Elanco

Elanco is 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 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy PurposeTM – is to advance the health of animals, people, the planet and our enterprise.

Our Culture

We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success. We value and champion new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Your Role

The Sterility Assurance Specialist will provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables of the manufacturing operations in the Biotech network to guarantee that the production and analytical processes are carried out with appropriate Sterility Assurance standards in alignment with Global procedures, GMP (Good Manufacturing Practices) and Regulatory expectations, as well as industry best practices.

Key Responsibilities

  • Serve as the primary technical expert in contamination control, aseptic processing, and sterilization, providing guidance and support to manufacturing operations and 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, including aseptic processing, media fills, and sterilization cycles.
  • Identify and troubleshoot issues related to sterility assurance, conduct root cause analyses, implement corrective actions, and drive continuous improvement initiatives to minimize process risks and optimize productivity.
  • Develop and deliver comprehensive training programs for operators, technicians, and other relevant personnel on sterility assurance principles, best practices, and regulatory requirements.
  • 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 (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), CFIA (Canadian Food Inspection Agency), 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 either 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 are essential.
  • Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.

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