Quality Assurance Associate - Elanco

At Elanco (NYCE: 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!

The Quality Associate provides daily assistance and guidance to issues such as non-conformance investigations, change controls, procedure/manufacturing batch record changes, validations, batch disposition, and qualification activities.  The QA Associate works as a team member within the operations teams to achieve site goals while maintaining a strong quality mindset. 

Functions, Duties, Tasks:

• Ensure regular presence and provide guidance in operational areas to monitor and ensure robust compliance and quality systems
• Assist with the day-to-day Quality operational activities (document review, batch disposition, material handling, self-inspections)
• Participate and contribute to root cause investigations, related CAPAs and technical writing of summary reports.
• Lead, mentor, and coach operations and support personnel on quality matters
• Effectively generate and/or review controlled documents to ensure adherence to quality systems, global quality standards and regulatory guidelines.
• Support during internal/external regulatory inspections
• Collaborates with cross-functional partners (i.e., operations, TSMS, engineering, QC, logistics, etc.) to reduce compliance risks and improve efficiency of quality systems.
• Participate in and contribute to Lean, Six-Sigma and Operational Excellence activities by providing guidance and ensuring adherence to quality systems.
• Assist with and oversee the implementation and adherence with the global quality standards.
• Serve on project teams to provide Quality and compliance guidance and input

Minimum Qualification:

• B.S. Degree or equivalent experience required; Microbiology/Biology/Chemistry/Engineering related degree preferred 
• Strong root cause analysis and technical writing skills required
• Minimum 2+ years of experience in a Quality related role – preferably in the pharmaceutical or a healthcare related industry
• Experience working in an FDA or USDA highly preferred
• Excellent communication, organization, and leadership skills

Additional Information:

• Location: Winslow, ME -Onsite (Relocation provided for qualified candidates)
• Shift: Day position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
• Travel: Minimal < 10%.

• Post offer Requirements: Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.

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