Quality Assurance Associate, On the Floor (2nd shift 2:00PM-10:00PM)

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns

8-week parental leave

Employee Resource Groups

Annual bonus up to 6%

401K matching

Job summary

Elanco Animal Health Incorporated is seeking a Quality Assurance Associate for the On the Floor shift (2nd shift 2PM-10:00PM). The role focuses on reviewing batch records, ensuring regulatory compliance, and driving continuous improvement in production processes.

The candidate will verify documentation, contribute to CAPA investigations, and train team members while adhering to USDA/FDA requirements and company procedures.

Qualifications

• Associate's Degree in a science-related field and relevant industry experience or a Bachelor's Degree in a science-related field (Biology, Chemistry, etc.).
• Previous experience with USDA/FDA regulatory requirements in a biological production environment.
• Previous experience utilizing computer programs such as Microsoft suite, SAP, Veeva, Learning One Source and other relevant electronic applications.

Responsibilities

• Review and approve product batch records and technical documentation associated with validation, deviations or change control activities (media fills, etc.).
• Track/report/and define continuous improvement goals, determine root cause for deviation/CAPA reports, and subsequent communication back to the Process Team.
• Audit production processes for compliance with global and local procedures and either create new or revise existing procedures as changes occur.
• Develops training plans and trains/qualifies others, including training outside of area of responsibility.
• Demonstrates understanding of regulations for various countries and provides input or approval accordingly.

Skills

Regulatory experience

Documentation

Quality systems

Education

Associate's degree in science

Bachelor's degree in science

Tools

Microsoft Suite

SAP

Veeva

Learning One Source

Job description

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 Associate, On the Floor (OTF) Shift: (2nd shift 2PM-10:00PM)

Your Responsibilities:

• Review and approve product batch records and technical documentation associated with validation, deviations or change control activities (media fills, etc.).
• Track/report/and define continuous improvement goals, determine root cause for deviation/CAPA reports, and subsequent communication back to the Process Team.
• Audit production processes for compliance with global and local procedures and either create new or revise existing procedures as changes occur.
• Develops training plans and trains/qualifies others, including training outside of area of responsibility.
• Demonstrates understanding of regulations for various countries and provides input or approval accordingly.

What You Need to Succeed (Minimum Requirements):

• Associate's Degree in a science-related field and relevant industry experience or a Bachelor's Degree in a science-related field (Biology, Chemistry, etc.).
• Previous experience with USDA/FDA regulatory requirements in a biological production environment.
• Previous experience utilizing computer programs such as Microsoft suite, SAP, Veeva, Learning One Source and other relevant electronic applications.

What Will Give You a Competitive Edge (Preferences):

• Ability to make decisions with minimal supervision regarding the acceptability of product based on documentation provided.
• Excellent attention to detail.
• Continuously demonstrates a high level of professionalism through interactions with internal and external customers.
• Must be capable of formulating new ideas for improving site performance and efficiency and working cohesively with all levels to implement ideas.

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:

• Multiple relocation packages for eligible positions
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 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.

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.