Quality Assurance Associate, On the Floor
Elanco
Your Role: Quality Assurance Associate
As a Quality Assurance Associate, you will support cGMP operations and ensure compliance across manufacturing processes by maintaining quality systems, supporting batch disposition, and partnering cross-functionally to drive compliance, investigations, and continuous improvement.
Responsibilities:
- Support batch disposition for incoming, in-process, and finished materials
- Review and approve quality documents including deviations, change controls, and validation protocols
- 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
Minimum qualifications:
- Bachelorβs Degree in a Science or Engineering field (or equivalent experience)
- Experience in quality systems, manufacturing, or regulated environments
- 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