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Quality Assurance Associate – Manufacturing Floor


Last Updated: 9/24/23

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.

Position Description:

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.

Functions, Duties, Tasks:

  • 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. Notifies management of issues and actions taken as needed.

  • 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. 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.

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

  • Issuance of cell banks for use in production activities.

  • Participates in internal audits as needed.

  • 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 the Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.

Basic Minimum Qualifications:

  • BA/BS (or Master's) in any Life Science discipline preferred, and/or 3 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.
  • Gowning out will be a part of this position requirement.
  • 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.

Additional Preferences:

  • Experience in Production record review prior to forward processing.
  • Understanding and experience in checking calculations for correctness.
  • Experience in deviations/investigations on front line groups.
  • Working understanding with production line- knowledge of regulatory needs and requirements on production.

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...