Quality Assurance Representative

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: Quality Assurance Representative As a Quality Assurance Rep , 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.

Requirements

Bachelor’s Degree or equivalent experience in a science-related field.
A minimum of 5 years of experience in cGMP within pharmaceutical manufacturing, or relevant life sciences experience.
Strong knowledge and application of cGMP principles in pharmaceutical or regulated manufacturing environments
Proficiency in quality systems processes, including batch record review, deviation investigations, change control, and use of SAP for quality and manufacturing documentation.

Nice To Haves

Experience in Quality Assurance, Quality Control, or Manufacturing in a regulated environment.
Proven ability to prioritize and manage multiple tasks effectively.
Experience with deviation investigations and change control processes.
Knowledge of industry regulations and compliance standards.
Experience using SAP in a GMP setting for quality and manufacturing operations.
CSQA certification or demonstrated understanding of CSQA principles.

Responsibilities

Provide production floor quality support by assisting with procedures, master batch records, and quality system monitoring, while ensuring GMP compliance and readiness for regulatory inspections.
Review and approve batch records and support batch release processes in alignment with internal procedures and regulatory requirements, utilizing SAP for documentation, materials management, and quality-related transactions.
Drive continuous improvement initiatives by coaching and supporting deviation investigations, change control proposals, and enhancements to quality systems and processes.
Collaborate with leadership and cross-functional teams to identify, implement, and verify improvements through self-inspections, internal audits, and other compliance assessments.
Provide guidance and feedback to operational staff on quality expectations, data integrity, and computer system validation principles, ensuring adherence to CSQA standards.