Quality Assurance Associate
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
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
- 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
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
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