What are the responsibilities and job description for the Quality Assurance Specialist position at US01 Elanco US Inc.?
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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
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 Specialist
As an Associate in Quality Assurance, you will play a crucial role in supporting Clinton Manufacturing Operations and ensuring that quality systems adhere to Good Manufacturing Practices (GMP). In this position, you'll be responsible for facilitating compliance, supporting continuous improvement initiatives, and providing guidance to operational staff.
Your Responsibilities:
Provide production floor support, including assistance with procedures, master batch records, and quality system monitoring.
Maintain GMP compliance in preparation for regulatory inspections.
Facilitate continuous improvement through coaching and support for deviation investigations and change control proposals.
Collaborate with the area director to drive improvements via self-inspections.
Offer coaching and feedback to operational staff.
What You Need to Succeed (minimum qualifications):
Education: Bachelor’s Degree or equivalent experience in a science-related field preferred.
Required Experience: A minimum of 3 years of experience in cGMP within pharmaceutical manufacturing.
Top Skills: Strong proficiency in computer systems (Microsoft Office, Document Management, Maintenance Management, Inventory, Quality Systems) and excellent communication skills.
What will give you a competitive edge (preferred qualifications):
Experience in Quality Assurance, Quality Control, or Manufacturing in a regulated environment.
Proven ability to prioritize and manage multiple tasks effectively.
Strong problem-solving skills and interpersonal abilities.
Experience with deviation investigations and change control processes.
Knowledge of industry regulations and compliance standards.
Additional Information:
Location: Clinton, Indiana 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:
Multiple relocation packages
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
Flexible work arrangements
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
