Senior Quality Associate, Sterility Assurance

3 weeks ago

Fort Dodge, United States Elanco Animal Health Incorporated Full time
At Elanco (NYSE: ELAN) - it all starts with animals

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better - join our team today

Your Role: Senior Quality Associate, Sterility Assurance

The Sterility Assurance Consultant 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. You will work cross-functionally to improve the site Sterility Assurance related processes and programs (aseptic training/qualification, APS (Aseptic Process Simulation) program, EM (Environmental Monitoring) program, etc.).

Your 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.
What You Need to Succeed (Minimum Qualifications):
  • B.S.in 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.
What Will Give You a Competitive Edge (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.
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose Some highlights include:
  • 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


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

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