Quality Assurance Assistant

Elanco; United States; On-site; USD 42,000 - 58,000; Full time

Benefits offered by this job

Two weeklong shutdowns (mid-summer and

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco is hiring a Quality Assurance Assistant at our Clinton, IN site to support site quality systems and ensure products meet cGMP standards and regulatory requirements. You will review data, maintain documentation, and collaborate cross-functionally to enable timely batch release and production support.

Responsibilities include organizing manufacturing records, document management, SOP routing, and cross-functional communication with Production, QC, and Supply Chain.

Qualifications

• Attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Experience in a manufacturing, quality, or regulated environment (cGMP preferred).

Responsibilities

• Review, organize, and maintain manufacturing records, ensuring accuracy and compliance with GMP standards.
• Support quality systems, including document management, SOP creation/revision, and routing documents through systems such as Veeva Vault.
• Partner with Production, QC, and Supply Chain to ensure timely batch release and communication of critical quality information.
• Prepare and manage documentation such as Certificates of Analysis, labels, and batch records to support production and customer requirements.

Skills

Attention to detail

Multi-priority management

Education

High School Diploma / GED

Tools

Veeva Vault

SAP

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 Assistant

As a Quality Assurance Assistant, you will support site quality systems to ensure products and packaging meet all applicable cGMP standards and regulatory requirements. In this role, you’ll be responsible for reviewing and analyzing data, maintaining documentation, and partnering cross-functionally to enable timely batch release and production support.

Your Responsibilities:

• Review, organize, and maintain manufacturing records, ensuring accuracy, completeness, and compliance with GMP standards
• Support quality systems, including document management, SOP creation/revision, and routing documents through systems such as Veeva Vault
• Partner with Production, QC, and Supply Chain to ensure timely batch release and communication of critical quality information
• Perform material-related quality activities including raw material approval, vendor COA review, and printed packaging inspectionPrepare and manage documentation such as Certificates of Analysis, labels, and batch records to support production and customer requirements

What You Need to Succeed (minimum qualifications):

• Education: High School Diploma / GED
• Required Experience: Experience in a manufacturing, quality, or regulated environment (cGMP preferred)
• Top 2 skills: Attention to detail and ability to manage multiple priorities in a fast-paced environment

What Will Give You a Competitive Edge (preferred qualifications):

• Experience working in a cGMP-regulated manufacturing environment
• Hands‑on experience with batch record review, material release, or quality documentation
• Familiarity with document management systems (e.g., Veeva Vault) and ERP systems such as SAP
• Experience supporting quality activities for packaging, labeling, or certificates (COAs, permits, etc.)
• Strong communication skills with ability to collaborate across Quality, Operations, and Supply Chain

Additional Information:

• Location: Clinton, IN Manufacturing Site

_ 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:
• 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

Elanco is a global animal health company dedicated to enhancing the health of pets and farm animals through innovative solutions, empowering caregivers for a healthier world.

Pharmaceutical Manufacturing Chemical Manufacturing Manufacturing

May 2017

Footprint

Where they work

Headquarters Indianapolis, IN