What are the responsibilities and job description for the Responsible Person - Quality and Product Release position at US01 Elanco US Inc.?
At 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!
Your Role: Responsible Person (RP), Quality
The purpose of this position is to provide final approval for filled product serials at the Elanco Fort Dodge vaccine site and submit to USDA for release to US market. This position will provide oversight of Quality Assurance processes ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production and Elanco standards, as well as technical guidance, training, and oversight regarding Quality and GMP for the site. Responsible Person is responsible for identifying and implementing new quality initiatives, systems, and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage.
Your Responsibilities:
Provide oversight of Quality Assurance processes ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production and Elanco standards.
Ensure product quality and compliance with regulatory requirements for released batches through review and assessment of batch documentation, analytical data, and associated deviations, change controls and CAPA.
Implement SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.
Assist with internal, regulatory, or corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
Provide training and guidance to personnel relating to GMP principles, quality procedures, and regulatory requirements.
What You Need to Succeed (minimum qualifications):
Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or Engineering.
10 years in a regulated pharmaceutical /vaccine manufacturing environment.
Thorough understanding of the principles and methods of vaccine manufacturing and formulation, sterility assurance, Quality Control testing and analysis, packaging, storage, and distribution.
Must demonstrate ability to work and communicate with diverse groups across the organization at all levels on a routine basis, locally and globally.
Well versed in all regulatory requirements, inclusive of cGMP/GLP
Significant working and theoretical knowledge are required to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment, and recommend improvements to improve compliance levels.
What Will Give You the Competitive Edge (preferred qualifications):
Ability to work and communicate with diverse groups across the organization at all levels on a routine basis, locally and globally.
Good knowledge of statistics, databases, and quality principles.
Makes routine decisions with limited guidance from management.
Don’t meet every single requirement? Studies have shown underrecognized 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:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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