Sr Quality Associate - AOR Process
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.
Are you looking for a company with a clear mission to advance the well-being of animals, people, and the planet? If so, join Elanco to help us realize our vision of Food and Companionship Enriching Life supporting three of our state-of-the-art, manufacturing facilities. We create farm & companion animal vaccines and are launching a new monoclonal antibody (mAb) that will potentially save 40,000 puppies a month from Parvovirus. Come make a difference with Elanco and pursue both your short- and long-term career goals. As a global leader in the animal health industry, Elanco offers a variety of career opportunities inside and outside of the Manufacturing & Quality function at exciting locations around the world.
The purpose of this position is to provide administrative coordination and technical direction to persons responsible for Annual Outline Review (AOR) and internal approval processes for Outlines of Production (OOP) and Special Outlines (SO), which are regulated documents with the USDA Center for Veterinary Biologics.
The position interacts with all areas of Manufacturing, Quality, and Regulatory Affairs to maintain compliance of operations as stated in the OOPs and SOs. This position will have responsibility for activities at all Est. 196 locations (Fort Dodge, IA, Winslow, ME, and Elwood, KS). This position shares successful processes and programs with other sites in Elanco network in order to build cross site processes.
Functions, Duties, Tasks:
Responsible for providing technical guidance, training, and oversight for the overall Est. 196 AOR program.
Leads, facilitates, and enables AOR and internal OOP and SO revision and approval process.
Ensures Est. 196 alignment of related processes and procedures.
Implements applicable Est. 196 SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.
Coordinates with departmental managers to strategically drive improvements in the AOR process.
Assist with the accuracy and compliance of controlled documents against the approved OOP/SO.
AOR process operates in an efficient manner, generating quality and timely results within an atmosphere which promotes collaboration and growth.
Outline updates are completed in a timely manner ensuring availably and accuracy of OOPs and SO to support production and laboratory operations.
Network collaboration and alignment with regulatory is achieved during the escalation, investigation, and reporting of outline non-compliance.
B.S./B.A. degree or equivalent experience in lieu of degree
Minimum 5 years of experience in a Quality or Regulatory role.
Good understanding of the relevant USDA regulations.
Well versed in regulatory requirements, inclusive of GMP/GLP
Ability to plan, schedule, organize, prioritize, and coordinate project activities in a Team environment.
Strong verbal, written, organizational, time management, and interpersonal skills with cross-functional groups.
Must be self-motivated and of high integrity.
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.
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
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