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 Auditor is part of the Elanco Global Quality Compliance and Auditing (EGQCA) organization and provides quality assurance through the execution of internal and external audits in support of pharmaceutical products, product commercialization for Elanco. Through auditing, the Quality Auditor assures that operations conducted and sponsored by Elanco are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations and applicable guidelines and industry standards.
Functions, Duties, Task:
These responsibilities are not intended to be all-inclusive:
• Scheduling, preparing, conducting and reporting Global Quality audits and assessments of commercial operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
• Participate in mock-inspections, as appropriate.
• Participate in or lead the risk assessment of commercial operations. Integrate the information obtained through auditing and risk assessment and influence actions within and across EGQCA and the business areas involved/impacted.
• Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.
• Understand and apply the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
• Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.
• Influence internal and external customers and partners when improvement needs are identified.
• Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
• Be continually aware of current industry trends and regulatory agency interpretation of requirements for Animal Health.
• Participate or lead improvement efforts, including operational projects.
Basic Minimum Qualifications:
Ability to analyze detailed technical scientific information, while understanding the bigger picture. The auditor should be able to clearly identify and assess risk and impact associated with specific findings and overall compliance status for an auditable unit, and to articulate such risk and impact when communicating to the business (including senior management) and the quality organizations.
• 8 years of experience supporting parenteral manufacturing
• Ability to interpret and apply regulations, regulatory guidance, codes and public expectations, and identify and recommend compliance changes as appropriate.
• Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
• Experience with computers, entering and managing data in databases.
• Good analytical/problem-solving skills.
• Bachelor’s Degree (or equivalent work experience) in physical or biological sciences, Engineering or other technical area.
• Previous auditing experience
• Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
• Proven ability to think and analyze from a process perspective. Project management skills.
• Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
• Work independently as well as collaboratively within a global team environment.
• Deliver constructive feedback to customers while providing a high level of customer service.
• Ability to influence and manage change/conflict.
• Establish and maintain effective working relationships at all levels internal and external to Elanco.
• Ability to think on your feet and be pragmatic in decision making.
• Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 50% (trip duration 1-2 weeks), sometimes on short notice.
Elanco currently anticipates that the base salary for this position could range from $116,300 to $164,800, depending partly on the successful candidate’s qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees.
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