Elanco needs to ensure robust quality and compliance in its animal health product manufacturing, requiring daily assistance and guidance on various quality-related issues to maintain high standards and facilitate timely product disposition.
Requirements
- Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency).
- Proven quality assurance experience in a regulated environment.
- Root cause analysis and troubleshooting skills.
- Technical writing skills.
Responsibilities
- Oversee and monitor quality systems, conduct thorough document reviews, and support regulatory inspections to maintain high standards.
- Assist with the timely disposition of incoming, semi-finished, and finished materials, ensuring adherence to quality protocols.
- Collaborate cross-functionally to investigate non-conformances, deviations, and CAPAs, leveraging Six Sigma tools and supporting Lean initiatives.
- Serve on project teams, offering expert input to ensure compliance and quality attributes are met throughout project lifecycles.
- 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.
Other
- Must not have contact with avian species (birds) at home due to the nature of the manufacturing.
- Demonstrate strong oral, written, and interpersonal skills.
- Strong ability to work on a team and lead without authority.
- B.S. Degree or equivalent Microbiology/Biology/Chemistry/Engineering (Science or Engineering related degree preferred).
- M.S degree is highly preferred.
