Elanco · 1 day ago
Quality Assurance Representative
Elanco is a global leader in animal health dedicated to innovation and delivering products to prevent and treat disease in farm animals and pets. The Quality Assurance Representative will support manufacturing operations by ensuring compliance with Good Manufacturing Practices and facilitating continuous improvement initiatives.
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
Qualification
Required
Education: Bachelor's Degree or equivalent experience in a science-related field
Required Experience: A minimum of 5 years of experience in cGMP within pharmaceutical manufacturing, or relevant life sciences experience
Top Skills: 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
Preferred
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
Benefits
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
Company
Elanco
Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.
H1B Sponsorship
Elanco has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
Funding
Current Stage
Public CompanyTotal Funding
$252.86MKey Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M
Leadership Team
Recent News
2026-01-03
2025-12-18
Company data provided by crunchbase