(Archived) 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 quality systems and compliance

• 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

Basic Minimum Qualification:

• B.S. Degree or Associates' + 2 years of relevant experience or equivalent experience in lieu of degree.

• Microbiology/Biology/Chemistry/Engineering related degree preferred

• 2+ years of experience in a Quality related role in the pharmaceutical or a healthcare related industry preferred

• Strong root cause analysis and technical writing skills

• Experience working in an FDA or USDA

• Excellent communication, organization, and leadership skills

• Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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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