(Archived) Senior Quality 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.

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.

Responsibilities:

• 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

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

Basic Qualification:

• Bachelor Degree or equivalent expertise and work experience (5 years of experience)
• 3 years quality assurance experience
• 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. Elanco does not anticipate visa sponsorship for this position (e.g. H1B)

Additional Requirements:

• Experience in GMP environment
• Knowledge of GDPs (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
• 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

Other Information:

• Position home is located at Elanco Headquarters with some periodic travel to other Elanco sites and Elanco external collaborators. Travel required as necessary to support the business needs.

Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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