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Form of workAt Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Making animals' lives better makes life better - join our team today!
Your Role: Advisor- Quality Assurance Auditor
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.
Your Responsibilities:
• 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.
What You Need to Succeed (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.
What will give you a competitive edge (preferred qualifications):
Additional Information:
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Relocation packages
#LI-JH1
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
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Making animals' lives better makes life better - join our team today!
Your Role: Advisor- Quality Assurance Auditor
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.
Your Responsibilities:
• 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.
What You Need to Succeed (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.
- Bachelor's Degree (or equivalent work experience) in physical or biological sciences, Engineering or other technical area.
- 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 with ability to thing from a process perspective.
What will give you a competitive edge (preferred qualifications):
- Previous auditing experience
- Proven ability to work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
- 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.
Additional Information:
- Travel: 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.
- Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Relocation packages
- Two week shut downs (mid-summer and year-end) in the US (in addition to PTO)
- 10-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
- Dependent and childcare support
#LI-JH1
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
