Quality Assurance Specialist

Posted 2 Days Ago
Be an Early Applicant
Clinton, IN
Mid level
Healthtech • Pharmaceutical • Manufacturing
The Role
As a Quality Assurance Specialist, you'll support manufacturing operations by ensuring adherence to Good Manufacturing Practices (GMP). Responsibilities include facilitating compliance, supporting continuous improvement initiatives, and coaching operational staff. You will maintain GMP compliance, assist in inspections, and drive quality improvement processes.
Summary Generated by Built In

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

The Company
HQ: Greenfield, Indianna
8,445 Employees
On-site Workplace

What We Do

At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives.

Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society.

Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco

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