Elanco · 6 hours ago
Quality Assurance Associate - Sterility
Winslow, ME
Full-time
Onsite
New Grad, Entry LevelElanco is a global leader in animal health dedicated to innovation and delivering products and services to improve the lives of animals. The Quality Assurance Associate will provide oversight and contributions to Sterility Assurance programs, ensuring compliance with global procedures and regulatory expectations.
ManufacturingPetSupply Chain Management
Responsibilities
Provide technical and SME input for various programs including Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, while maintaining lifecycle documentation
Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to all relevant policies and regulations
Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans
Assist in troubleshooting, performing gap/risk assessments, providing support for regulatory inspections, and conducting necessary training
Provide oversight during the execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support corrective actions including RCI and CAPA
Qualification
Required
B.S.in engineering, microbiology/biology, or equivalent discipline
Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency)
Preferred
Experience with parenteral, biological, or vaccine manufacturing operations, environmental monitoring, aseptic processing, and sterile gowning
Experience with sterile manufacturing risk assessments and remediations implementation
Lean manufacturing and six sigma experience
Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment are essential
Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously
Benefits
Multiple relocation packages for eligible positions
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.
Founded in 1954
5001-10000 employees
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
Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
Jennifer Black
Senior Director, Global Indirect Procurement
Recent News
2026-01-03
2025-12-18
Company data provided by crunchbase