Senior Associate-Quality Assurance

Elanco•Clinton, IN

2d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field
A minimum of 2 years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment
Proficiency in cGMP regulations and experience with quality documentation systems

Nice To Haves

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

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.