(Archived) US Quality Assurance Consultant

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.

As a quality contact for the Elanco Affiliate organization, the Quality Consultant 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. The person will ensure that all operations of the affiliate comply with applicable company quality standards and local regulations.

Functions, Duties, Tasks:

• Ensure that distribution, product release and warehousing is 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.
• Maintain Quality procedures in a state of inspection readiness (aligned with relevant Standards and Regulations).
• Maintain training compliance.
• Provide Quality support and education to affiliate staff.
• 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.

Minimum Qualifications:

• Bachelor Degree or equivalent expertise and work experience.
• Solid experience in Quality Assurance in pharmaceutical company.

Additional Requirements:

• Experience in GMP environment.
• Knowledge of Good Distribution Practices.
• Experience with SAP, 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 in English.
• Demonstrated ability to communicate effectively, both written and verbal in English.
• 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.

Other Information:

• Location: Greenfield, IN (Hybrid)
• Travel: Minimum expected (5-10%). The majority of travel will be planned rather than emergency / unplanned.

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