Quality Assurance Advisor, Sterility Assurance
在 Elanco (NYSE:ELAN) 一切都从动物开始！作为全球动物健康领导者，我们致力于创新和提供农场动物和物疾病预防和治疗的产品和服务。在 Elanco,我们以我们的食品与伙伴关系丰富生活愿景以及我们的目标为动物，客户，社会和人民而言所做的一切做出了更多努力。在 Eranco,我们自豪地培养多样化和包容的工作环境。我们相信多样性是创新的驱动力，创造力和整体商业成功。在这里，你将成为一个公司的一部分，它重视和支持新的思维方式，与动态的人员合作，并获得新技能和经验，这将推动你的职业生涯到新的高度。使动物生活更好让生活更好！今天加入我们的团队！你的角色：质量保证顾问，无菌性保证网络水平无菌性保障顾问提供关键监督和直接贡献在生物技术网络中无菌性确保/污染控制战略的成果，确保制造运营符合全球程序，GMP,监管期望和行业最佳实践。作为专家，这项角色涉及与生产，QC 和 TS/MS 团队的跨职业合作。主要目标是改善现场不孕育能力保证计划，包括无菌培训/资格，无菌过程模拟 (APS),污染控制和环境监测 (EM).你的责任：·为各种程序提供技术和中小企业输入，包括工艺，无菌，清洁验证和污染控制策略，同时保持生命周期文件。· 与区域所有者和供应商合作，完成设施，工艺，设备和系统的验证/资格要求，确保遵守所有相关政策和法规。· 撰写并开发埃兰科对污染控制，无菌/性过程，清洁和消毒验证计划的功能程序 (EFP). ·协助解决故障，执行差距/风险评估，支持监管检查以及进行必要培训。· 监督制造，无处理，媒体填充，媒体持有和灭菌周期的 （重新）验证/资格活动执行过程中，并支持包括 RCI 和 CAPA 在内的纠正行动。
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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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
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: Quality Assurance Advisor, Sterility Assurance
The Network Level Sterility Assurance Advisor provides critical oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables within the Biotech network, ensuring manufacturing operations meet global procedures, GMP, regulatory expectations, and industry best practices. Acting as a subject matter expert, this role involves cross-functional collaboration with production, QC, and TS/MS teams. The primary goal is to improve site Sterility Assurance programs, including aseptic training/qualification, Aseptic Process Simulation (APS), contamination control, and Environmental Monitoring (EM).
Your Responsibilities:
- Provide technical and SME input for various programs including Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, while maintaining lifecycle documentation.
- Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to all relevant policies and regulations.
- Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans.
- Assist in troubleshooting, performing gap/risk assessments, providing support for regulatory inspections, and conducting necessary training.
- Provide oversight during the execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support corrective actions including RCI and CAPA.
What You Need to Succeed (minimum qualifications):
- B.S.in engineering, microbiology/biology, or equivalent discipline.
- 10+ years' experience with parenteral, biological, or vaccine manufacturing operations, environmental monitoring, aseptic processing, and sterile gowning
- Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency)
What Will Give You the Competitive Edge (preferred qualifications):
- Masters or PhD preferred.
- Lean manufacturing and six sigma experience.
- Experience with sterile manufacturing risk assessments and remediations implementation.
- 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.
Additional Information:
· Remote position with occasional travel (up to 30%)
Don't meet every single requirement? Studies have shown underrecognized 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
- 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
- Flexible work arrangements
- 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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Originally posted on Himalayas