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

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 52,000 - 70,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (mid-summer and

year-end) in the US

8-week parental leave

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco is hiring a Quality Assurance Associate on the floor (OTF) for the 2nd shift (2PM-10PM) in Fort Dodge, IA. The role supports Process Teams by reviewing batch records, investigating deviations, and driving CAPA actions.

You will train staff, audit processes for GMP/GDP compliance, and coordinate with Process Team Lead and Quality Lead. Requirements include an associate or bachelor degree in a science field, plus experience with USDA/FDA rules in biotech production and proficiency with MS

Qualifications

• Associate degree in science with relevant experience or a B.S. in science.
• Experience with USDA/FDA regulatory requirements in biological production.
• Proficient with MS Office, SAP, Veeva or related systems.

Responsibilities

• Review and approve batch records and related documentation.
• Track and report continuous improvement goals; root-cause analysis for deviations.
• Audit production processes for compliance and update procedures as needed.
• Develop and deliver training plans for staff in GMP/GDP practices.
• Ensure regulatory understandings for different countries are implemented.

Education

Associate's Degree in a science-related field

Bachelor's Degree in a science-related field

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)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.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: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 positionsTwo weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)8-week parental leave9 Employee Resource GroupsAnnual bonus offeringUp to 6% 401K matchingElanco 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 statusElanco 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.