Quality Assurance Associate - on the floor
Elanco · Winslow, ME · 4 wk ago
Quality AssuranceFull-time
About the role
As a Quality Assurance Associate at Elanco, you will be part of the Quality team to support cGMP operations and ensure compliance across manufacturing processes.
Responsibilities
- Support batch disposition for incoming, in-process, and finished materials
- Review and approve quality documents including deviations, change controls, and validation protocols
- Partner cross-functionally to investigate non-conformances and drive CAPAs
- Provide guidance to operations teams to ensure compliance with quality systems and regulatory standards
- Support internal and external audits and contribute to continuous improvement initiatives
Requirements
- Education: Bachelor’s Degree in a Science or Engineering field (or equivalent experience)
- Experience: Experience in quality systems, manufacturing, or regulated environments
- Top 2 skills: Strong problem-solving/root cause analysis + effective communication and collaboration
Preferred qualifications
- Experience in pharmaceutical, biotech, or regulated (FDA/USDA) environments
- Knowledge of Lean, Six Sigma, or Operational Excellence methodologies
- Experience with deviations, CAPAs, and quality investigations
- Strong technical writing and documentation review skills
- Ability to lead and influence in a cross-functional team environment
Benefits
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.