Quality Assurance Associate - Elwood, United States - Elanco Animal Health Incorporated

Elanco Animal Health Incorporated Elwood, United States

6 days ago

Description

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 PurposeTM - 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

This position coordinates and performs activities for the Quality Assurance Department regarding material/printed packaging release, specifications and internal/external audits. This position also has specific responsibilities for other quality and compliance related activities as directed by the Quality Assurance Manager/Director. This position works very closely with the Manufacturing, Procurement/Logistics, TSMS and Warehouse Departments.

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, TSMS and Manufacturing in day-to-day processes.
Management of material and packaging specifications. Including drafting, periodic review, supplier change notifications and revision updates.
Conduct and oversee supplier/service provider qualification and management activities.
Analyzes and interprets projects or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
Identifies, investigates and resolves complex technical issues using problem-solving skills. Notifies management of action taken.
Participates/conducts internal and supplier/service provider audits as needed.
Performs Gap assessments for material/packaging/labeling specifications and Standard Operating Procedures.
Drafts, routes and completes change controls, deviations, and CAPA records when required within the Veeva Quality Management System.
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.
Participates and manages QA projects as needed. Receives minimal supervision on work assignments. Receives overall project direction from management but completes most work independently.
Assists in the archival of records and files.
Assists the Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.
Conduct SAP movements for the release of materials and confirms SAP information is correct.

Minimum Qualifications:

BA/BS in any Life Science discipline preferred or relevant experience in lieu of a degree.
5 years' experience in regulated industry (USDA, FDA, ISO etc).
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.
Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
Demonstrated experience making sound independent decisions.
Excellent verbal and written communication skills.
Must display eagerness to learn and continuously improve.
Positive work attitude that supports teamwork and continuous improvement.
Demonstrated experience and proficiency in Microsoft Office applications; Word, Excel and PowerPoint.

Other Information:

Location: Elwood, KS (Onsite)
Travel: Minimal, less than 5%.
Shift: Standard work week with occasional nights and weekends.

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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