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Last Updated: 5/24/23

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.

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. This position works very closely with the Manufacturing 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 and Manufacturing in day-to-day processes.
  • Management of material and packaging specifications. Including drafting, annual review and revision updates.
  • 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 in internal or supplier 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.

Basic Minimum Qualifications:

  • BA/BS in any Life Science discipline or5 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 be able to read, write, and converse in English.
  • 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.

Additional Information:

  • 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.
  • Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.

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

Company Details

Greenfield, Indiana, United States
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health...