Quality Control Coordinator (Project Management)
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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
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 Control Coordinator
The QC Senior Associate, reporting to the Quality Control Manager, oversees sample coordination for raw materials, bulk product, final product, and experimental samples submitted to Quality Control. This role requires collaboration with other departments to ensure accurate labeling, storage, and testing, along with organizing controlled documentation and distributing it to laboratories and regulatory agencies. Additionally, the Senior Associate reviews and corrects primary testing documentation and participates in audits and inspections.
Your Responsibilities:
Manages the distribution of controlled documents and ensures proper handling of production samples, including chain of custody maintenance and storage.
Oversees the submission and shipping of samples, including USDA submissions, following regulatory guidelines.
Assembles testing documentation packets and summary reports for QA release submissions and distributes non-release testing data reports.
Manages QC material ordering, supply room organization, and document filing.
Develops, reviews, and implements SOPs, oversees electronic systems (e.g., LIMS, SAP), and participates in audits and inspections.
What You Need to Succeed (minimum qualifications):
HS diploma or GED and at least 5 years of experience, or BA or BS degree in a scientific discipline preferred with at least 3 years of experience, in cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment.
Prior experience related to quality control testing or systems in a pharmaceutical environment.
Analytical Skills: Highly analytical and strong advocate for process improvement.
What will give you a competitive edge (preferred qualifications):
Experience in Materials Management for USDA or FDA regulated industries.
Experience with LIMS, SAP, JMP, Veeva Vault.
Excellent technical writing skills.
Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.
Experience with performing audits and inspections.
High attention to detail when performing documentation and process reviews.
Additional Information:
This is a full-time permanent salaried position.
This is considered an on-site position.
Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
Minimal travel requirements < 5%.
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:
Relocation packages
10-week parental leave
9 Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching
Dependent and childcare support
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
