Quality Assurance Advisor, Sterility Assurance

Elanco; United States; Presencial; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

Annual bonus

Flexible work arrangements

8-week parental leave

401K matching

Descripción de la vacante

Elanco is seeking a Quality Assurance Advisor, Sterility Assurance, to oversee and contribute to Sterility Assurance/Contamination Control within the Biotech network. You will collaborate cross-functionally to improve aseptic programs, training, APS, EM, and overall compliance with GMP and regulatory expectations.

The role involves authoring EFPs, supporting validations, and providing SME input across processes, equipment, and facilities.

Formación

• B.S. in engineering, microbiology/biology, or equivalent discipline.
• 10+ years' experience with parenteral, biological, or vaccine manufacturing operations.
• Familiarity with FDA, EU GMP, USDA, and CFIA regulations.

Responsabilidades

• Provide technical and SME input for Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, maintaining lifecycle documentation.
• Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to policies and regulations.
• Author and develop Elanco Functional Procedures for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans.
• Assist in troubleshooting, perform gap/risk assessments, support regulatory inspections, and conduct necessary training.
• Provide oversight during execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support CAPA.

Conocimientos

Sterility Assurance

Aseptic Processing

Environmental Monitoring

Process Validation

Regulatory Compliance

QA Collaboration

Educación

B.S. in engineering or microbiology

Descripción del empleo

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%)

Elanco Benefits and Perks:

• 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 #LI-KG2
• 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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.