Quality Assurance Associate, On the Floor

Elanco•Winslow, ME

1d•Onsite

About The Position

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! Your Role: Quality Assurance Associate, On the Floor 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.

Requirements

B.S. Degree or equivalent in Microbiology/Biology/Chemistry/Engineering or related field.
Root cause analysis and troubleshooting skills.
Demonstrate strong oral, written, and interpersonal skills.
Must not have contact with avian species (birds) at home due to the nature of the manufacturing.

Nice To Haves

M.S degree highly desirable.
Experience working in an FDA or USDA regulated industry.
Knowledge of or experience in Lean, Six-Sigma or Operational Excellence.
Experience in Quality Systems – preferably in the pharmaceutical or a healthcare related industry.

Responsibilities

Provide direct oversight and guidance in operational areas to ensure robust quality systems, compliance with GMP and EGQS, and readiness for internal/external regulatory inspections.
Assist with batch disposition for incoming, semi-finished, and finished materials, and effectively review/approve controlled documents including non-conformances, procedures, and validation protocols.
Lead and collaborate with cross-functional teams to investigate deviations, assess non-conformances, reduce compliance risks, and define/ensure effectiveness of Root Cause Investigations (RCI) and CAPAs.
Lead, mentor, and coach operations and support personnel on quality matters, and provide guidance for Lean, Six-Sigma, and Operational Excellence initiatives.
Serve on project teams to provide Quality and compliance input and assist with day-to-day Quality operational activities and material handling.