Senior Associate-Quality Assurance

Posted 7 Days Ago
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Clinton, IN, USA
In-Office
Senior level
Healthtech • Pharmaceutical • Manufacturing
The Role
Support site GMP compliance and quality systems by leading laboratory investigations, method validation, deviation and change control management, PQR/validation document authoring, internal audits, inspection readiness, training, and cross-functional collaboration to maintain product quality.
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. 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: Senior Associate – Quality Assurance 

As a Senior QA Representative, you will be part of the Clinton Quality Control Unit to deliver essential support for quality systems and GMP compliance. In this role, you’ll be responsible for advancing laboratory investigations, method validation, and continuous improvement initiatives through coaching and change control implementation. 

Your Responsibilities: 

  • Provide quality control support by providing assistance and guidance in laboratory investigations, Product Quality Reviews (PQR), and method validation activities. 

  • Maintain GMP compliance and inspection readiness for regulatory agencies through periodic audits and inspections of production areas. 

  • Facilitate continuous improvement by authoring and supporting deviation investigations and implementing change control proposals. 

  • Collaborate effectively across cross-functional QC teams, including laboratory technicians, chemists, and analysts, to ensure quality standards. 

  • Investigate customer complaints and review critical quality documents, including validation and PQR. 

  • Support and strengthen site Quality Systems by writing and revising SOPs, delivering site training, conducting internal audits, verifying inspection readiness, monitoring quality metrics, and representing the site in corporate knowledge-sharing forums. 

What You Need to Succeed (minimum qualifications): 

  • Education: Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field 

  • Experience: A minimum of 2 years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment 

  • Top Skills: Proficiency in cGMP regulations and experience with quality documentation systems 

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

  • Experience coaching or providing technical feedback to QC staff 

  • Proven ability to handle non-standard requests and participate in regulatory audits 

  • Strong technical writing skills for authoring validation and PQR documents 

  • Experience with change control implementation and deviation management 

  • Demonstrated ability to work effectively in cross-functional team environments 

Additional Information:

  • Location: Clinton, IN – Onsite Manufacturing Facility

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

  • Up to 6% 401K matching

#LI-KG2

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.

Skills Required

  • Bachelor's degree in Chemistry, Biology, Pharmacy, or related scientific field
  • Minimum 2 years experience in Quality Assurance, Quality Control, or regulated GMP manufacturing environment
  • Proficiency in cGMP regulations and experience with quality documentation systems
  • Onsite work at Clinton, IN manufacturing facility
  • Experience coaching or providing technical feedback to QC staff
  • Experience participating in regulatory audits and handling non-standard requests
  • Strong technical writing skills for authoring validation and PQR documents
  • Experience with change control implementation and deviation management
  • Demonstrated ability to work effectively in cross-functional team environments

Elanco Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elanco and has not been reviewed or approved by Elanco.

  • Leave & Time Off Breadth Time off options are broad, including PTO, flexible leave, and the ability to purchase additional vacation. These provisions are highlighted as supportive of work-life balance.
  • Healthcare Strength Health coverage includes medical, dental, and vision alongside company-paid life, disability, and wellness support. Pet insurance and assistance programs reinforce a comprehensive wellbeing offering.
  • Retirement Support Retirement offerings include a U.S. 401(k) and, for some employees, access to a defined benefit pension. These programs add meaningful long-term value to total rewards.

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The Company
HQ: Indianapolis, IN
8,445 Employees

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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