Quality Assurance Associate, On the Floor (2nd shift 4PM-2:30AM)

Elanco; Fort Dodge (IA); Hybrid; USD 52,000 - 68,000; Full time

Benefits offered by this job

Relocation packages

Annual bonus

401K matching

Parental leave

Job summary

Elanco in the United States is seeking a Quality Assurance Associate for the on-the-floor role on the 2nd shift (2PM-10:00PM). You will support Process Teams by reviewing batch records, identifying deviations, and writing investigation reports.

You will audit processes for GMP/GDP compliance, train staff, and collaborate with the Process Team Lead and Quality Lead to drive continuous improvement across site operations.

Qualifications

• Review and approve product batch records and related documentation.
• Track and define continuous improvement goals; identify root causes for deviations.
• Audit production processes for compliance and update procedures accordingly.
• Develop training plans and train/qualify others, including cross-area training.
• Demonstrate understanding of country regulations and provide input as needed.

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

Attention to detail

Decision making

Customer communication

Idea generation

Education

Associate's Degree in a science-related field

Bachelor's Degree in a science-related field

Tools

SAP

Veeva

Learning One Source

Microsoft Office

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) This position supports the Process Teams by tracking/reporting/and defining continuous improvement goals, on-the-floor batch record review/determining root cause for deviations/investigation report writing, coaching/training personnel on GMP/GDP, auditing production processes for compliance to global and local procedures, and closely working with and reporting to the Process Team Lead and Quality Lead.

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.

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
• 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.

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.