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As a quality contact for the Elanco Affiliate organization, the Quality Associate is responsible for day-to-day inventory activities relating to Elanco products distributed in the US market, including but not limited to product release for Elanco US sales & marketing, operations, and distribution. They will ensure that all operations of the affiliate comply with applicable company quality standards and local regulations.
- Ensure that distribution, product release and warehousing is in compliance with Elanco standards and external regulatory requirements
- Review batch documentation including temperature data (as needed) for product release to the market
- Manage inventory via SAP transactions
- Halt, hold or quarantine product, if and when required
- Process product returns
- Responsible for the completion and accuracy of operational quality tasks, including but not limited to change controls, deviations, protocols, risk assessments, root cause analysis and quality agreements
- Provide Quality oversight to third party warehouses including inspections, process improvement and monitoring Quality Agreement compliance
- Demonstrate continuous improvement and minimize risk
- Escalate any local product quality related issue to quality leadership and affiliate management
Additional duties include:
- Maintain Quality procedures in a state of inspection readiness (aligned with relevant Standards and Regulations)
- Maintain training compliance
- Provide Quality support and education to business partners
- Conduct affiliate self-inspections
- Ensure timely completion of Quality Plan items, CAPAs, self-inspections, deviation, recalls, etc.
- Support launch and acquisition activities
- Ensure immediate reporting of significant safety issues
- Bachelor Degree or equivalent expertise and work experience
- 3 years quality assurance experience
- Experience in SAP
- Minimum travel expected (5-10%). The majority of travel will be planned rather than emergency / unplanned.
- Qualified candidates must be legally authorized to be employed in the United States.
- Experience in GMP environment
- Knowledge of GDPs (Good Distribution Practices)
- Experience with Document Control systems and CAPA systems
- Ability to work independently and as part of a team. Must have excellent time management skills to effectively manage multiple responsibilities Demonstrated technical writing experience
- Demonstrated ability to communicate effectively, both written and verbal; good interpersonal skills; ability to communicate and collaborate with all levels
- Demonstrated ability to prioritize and handle multiple concurrent tasks; good planning and organization skills
- Demonstrated initiative and ability to influence, challenge, and work on cross-functional teams
- Demonstrated attention to detail
- Strong self-management/motivation, strong curiosity skills with the ability to anticipate problems and provide potential solutions and work to resolution
- Demonstrated ability to make decisions within scope of responsibility
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