Associate-Quality Assurance 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.

Quality Assurance Associate I-II: Floor

Position Title:

Quality Assurance (QA) Associate I-II: Floor

Supervisor Title:

Quality Assurance Manager

Job Level:

P1-P2

Position Type:

Full Time

Job Function:

Quality

Location:

Elwood, KS USA

Position Description:

This position coordinates and conducts activities of the Quality Assurance Department regarding material movement and 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. 

Basic Minimum Requirements:

• BA or BS degree in Biological Sciences, Pharmaceutical Sciences, or a closely related field with a preference of a minimum of 3 years of direct experience in a regulated (USDA, FDA, ISO etc.) manufacturing environment.


• Required to have working knowledge of SOP’s and experience in compliance to governmental regulations (USDA and/or FDA). 


• Must be proficient in both Word and Excel, and overall quality education and assessment is required.  


• Must possess advanced oral and written communication skills. 


• Must be adept at always communicating with tact and professionalism, internally and externally, while fostering mutually beneficial results. 


• Must have above average organizational skills and exceptional attention to detail.

Functions, Duties, Tasks:.

• Responsible for quality assurance duties for material movement including the disposition, hold and reject of incoming materials.   


• Interacts and supports compliance by leadership and example with Warehouse and Manufacturing in day-to-day processes.


• Provides quality floor support for manufacturing activities.


• 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. 


• Reviews/approves change management documentation, deviations, investigations and CAPA records.


• Participates in investigation teams and assists in the proper close out and follow up actions.


• Represents QA on cross-functional project teams. 


• Writes new documents and revises existing QA documents.


• Receives minimal supervision on work assignments.  Receives overall project direction from management but completes most work independently.


• Assist in the archival of records and files.


• Assists the Quality Assurance Associates and Quality Assurance Manager as needed.


• Understands and applies comprehensive knowledge of quality and cGMP/cGDP principles and maintains current understanding of global cGMP manufacturing regulations

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

Salary: