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Senior Quality Associate, Sterility Assurance Specialist
1 month ago
About Elanco
At Elanco, we're dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is 'Food and Companionship Enriching Life,' and we're committed to sustainability through our Elanco Healthy PurposeTM.
We foster a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and business success. As a Senior Quality Associate, Sterility Assurance, you'll be part of a dynamic team that values new ways of thinking and collaboration.
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. You'll work cross-functionally to improve site Sterility Assurance related processes and programs, ensuring adherence to regulatory requirements and industry best practices.
Your Responsibilities
- Serve as the primary technical expert in contamination control, aseptic processing, and sterilization, providing guidance and support to manufacturing operations.
- 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, implement corrective actions, and drive continuous improvement initiatives.
- 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
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.
