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

Elanco; Fort Dodge (IA); Presencial; USD 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

Shutdowns (mid-summer and year-end)

Parental leave

Employee Resource Groups

Annual bonus

401K matching

Descripción de la vacante

Elanco, a global leader in animal health, is seeking a Quality Assurance Associate on-the-floor for the 2nd shift (4PM-2:30AM) to support process teams with batch records, deviations, and continuous improvement. You will review documentation, investigate root causes, and ensure GMP/GDP compliance across multiple countries.

Ideal candidates hold a science degree with regulatory experience and are proficient with SAP, Veeva, and Microsoft Office in a dynamic manufacturing setting.

Formación

• Associate's or Bachelor's degree in a science-related field (Biology, Chemistry, etc.).
• Experience with USDA/FDA regulatory requirements in a biological production environment.
• Experience using computer programs such as Microsoft Office, SAP, Veeva, Learning One Source and other electronic applications.

Responsabilidades

• Review and approve product batch records and technical documentation related to validation, deviations or change control activities.
• Track, report and define continuous improvement goals; determine root cause for deviation/CAPA reports; communicate back to the Process Team.
• Audit production processes for compliance with global/local procedures; create or revise procedures as changes occur.
• Develop training plans and train/qualify others, including outside the area of responsibility.
• Demonstrates understanding of regulations for various countries and provides input or approval accordingly.

Conocimientos

GMP/GDP

Batch records review

Audit/compliance

SAP

Veeva

Microsoft Office

Training/teaching

Educación

Associate's degree (science)

Bachelor's degree (science)

Herramientas

Microsoft Office

SAP

Veeva

Learning One Source

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 Associate, On the Floor (OTF)

Shift: (2nd shift 4PM-2:30AM)

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 interactionswith 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:

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 packagesfor 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.