Want to know if this job is worth applying to?
Winslow, Maine, United States
Onsite
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!
As a Quality Control (QC) Assistant – Technical Reviewer, you will be a vital part of the Operations team, providing essential technical and compliance support to QC laboratory operations. In this role, you will be responsible for evaluating technical documentation for completion and accuracy, ensuring that all methods are performed as written and within internal, site, and regulatory guidelines.
Your Responsibilities:
· Compliance & Technical Support: Manage, review, and support technical documentation to ensure strict adherence to internal policies and regulatory requirements, including USDA and 9 CFR standards.
· Documentation Management: Take responsibility for reviewing, maintaining, and updating testing documents, supporting records, regulatory filings, and Quality Control procedures.
· Records & Reporting: Maintain accurate and concurrent testing records in accordance with USDA regulations. Compare test results against prescribed parameters and report findings to QC Leadership and other relevant departments.
· Administrative Excellence: Execute administrative support tasks, including the management of raw materials documentation and requisition processes.
· Business Partnering: Interface effectively with Clinical Operations, Quality Assurance, and Manufacturing across a variety of technical disciplines to provide compliance and technical guidance to laboratory personnel.
What You Need to Succeed (minimum qualifications):
· Education: Associate’s degree in biological sciences or a related field with a minimum of 5 years of quality and/or laboratory experience; OR a Bachelor’s degree in biological sciences with a minimum of 4 years of quality and/or laboratory experience.
· Skills: Advanced proficiency with MS Word and Excel, along with excellent planning and organizing skills. You must demonstrate strong analytical and problem-solving abilities.
· Documentation Practices: A deep understanding of Good Documentation Practices (GDP), including the ability to write, follow, and comprehend complex written procedures.
· Communication: Excellent written and oral communication skills with high attention to detail.
· Compliance Awareness: A foundational understanding of compliance policies and regulatory environments.
What will give you a competitive edge (preferred qualifications):
· Specialized Knowledge: Direct experience in bacteriology and virology.
· Regulatory Expertise: Previous experience working within USDA or 9 CFR regulated environments.
· Process Improvement: Demonstrated ability to identify documentation trends and suggest improvements to site procedures.
Must be able to pass a background check and gain Select Agent clearance.
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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.