Quality Assurance Associate – Manufacturing Floor at Elanco in Elwood, Kansas

Job Description:

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.

Why Work at Elanco? We Save Puppies!

Working at a monoclonal antibody start-up facility in Elwood, Kansas presents an exciting opportunity to contribute to cutting-edge research: Monoclonal antibodies are an innovative type of biologic drug that can target specific molecules in the body to treat a variety of diseases, including cancer and autoimmune disorders. Working at a start-up facility that is developing and manufacturing these drugs at a commercial scale is an opportunity to be on the forefront of medical research and contribute to developing treatments that can have a significant impact on pets' lives. Our newest product is a one-time injection that is 100% effective in curing the deadly parvovirus in puppies!  Elwood is 60 min North of downtown Kansas City and 15 min from St. Joseph, MO. 

Summary:

This position coordinates and conducts activities of the Quality Assurance Department regarding manufacturing floor support.  This position also has specific responsibilities for other quality and compliance related activities as directed by the Quality Assurance Manager.  This position works very closely with the Manufacturing and Warehouse Departments. 

Responsibilities:

• Interacts and supports compliance by leadership and example with Manufacturing in day-to-day processes. Provides quality floor support for manufacturing activities.


• Represents QA on cross-functional process teams.


• Observe daily active processes for: status, issues, concerns, and progress. Participate as QA representative first responder to issues within Manufacturing.


• Must be able to work in controlled / clean room environments requiring gowning qualifications.


• Performs QA review/approval of controlled documents including, but not limited to, solution records, batch records, logbooks, autoclave cycles with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls. 


• Participates in investigation teams and determine next steps. Assists in the proper close out and follow up actions. 


• Identifies, investigates, and resolves complex technical issues using problem-solving skills. 


• Reviews change management documentation, deviations, investigations and CAPA records for completion.


• Issuance of cell banks for use in production activities.


• Writes new documents and revises existing QA documents.

Minimum Qualifications:

• BA/BS in any Life Science discipline and 3+ years’ related experience OR High School Diploma/GED and 6+ years' related experience


• Must have direct experience with Quality Assurance within regulated industry (USDA, FDA, ISO, etc.)


• Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations.


• Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.


• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion.


• Demonstrated experience making sound independent decisions.


• Excellent verbal and written communication skills and ability to work effectively and efficiently in a team environment to accomplish goals.


• 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.

#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