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Quality Assurance Assistant

2 months ago

Clinton, United States Elanco Full time

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 Assistant

As a Quality Assurance Assistant, you’ll be a key player in maintaining and improving our site’s Quality Systems and Document Control processes. Your primary focus will be on ensuring compliance with cGMP and Elanco requirements through effective document management, batch disposition, and quality support.

Your Responsibilities:

  • Issue and review batch records, logbooks, and forms for compliance with Good Documentation Practices and SOPs.

  • Address minor documentation issues such as errors or missing information in accordance with SOPs.

  • Maintain and manage the Document Control system to ensure proper filing, storage, and retrieval of documents.

  • Provide document formatting support and train site personnel on good documentation practices.

  • Assist with internal and external regulatory inspections and support day-to-day quality operations.

What You Need to Succeed (minimum qualifications):

  • Education: High School Diploma or GED

  • Required Experience: Minimum of 3 years of relevant experience

  • Top 2 skills: Experience in quality systems and document control within a regulated industry; strong problem-solving abilities and proficiency with relevant computer systems.

What will give you a competitive edge (preferred qualifications):

  • Experience in an FDA or USDA regulated industry.

  • Strong communication, organizational, and leadership skills.

  • Proficiency in Excel, Word, and PowerPoint.

  • Familiarity with document retention programs.

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