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.
The Assistant – Quality provides daily assistance to maintain site Quality Systems and Document Control. The purpose of this position is to support the site’s overall document control, batch disposition, and quality systems. The position issues documentation, assists site by formatting documents, provides document control support, files documentation appropriately, maintains document control system, and ensures compliance with site requirements for documentation. The incumbent works as a QA team member to ensure product and site compliance with cGMP and Elanco requirements and achieve site goals while maintaining a strong quality mindset.
Functions, Duties, Tasks:
- Issues batch record/ logbook/form documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards as applicable
- Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP
- Ensure Document Control systems are established and implemented to facilitate system of filing and retrieval of documentation
- Maintains document control area in a state of control and compliance
- Ensure documents are stored, traceable and retrievable through the approved retention policy
- Supports site with formatting documents as needed
- Provides training on good documentation practices for the site
- Ensures SOPs are compliant with the site procedure
- Processes records through site Electronic Document Management System as needed
- Participates in deviation and change control processes as necessary
- Provides support to ensure robust quality systems and compliance
- Provides support during internal/external regulatory inspections
- Assists with the day-to-day Quality operational activities as needed (batch disposition, compliance checks, material handling)
- Serves on project teams as assigned
- Other duties as assigned
Basic Minimum Qualifications:
- HS diploma or GED with 5 years of relevant experience or an Associate’s degree with 3 years of relevant experience.
- Demonstrated strong oral, written, and interpersonal skills
- Demonstrated ability to work on a team
- Excellent problem-solving skills
- Root cause analysis and troubleshooting skills
- Proficiency with applicable computer systems
- Ability to work independently with minimal supervision
- Self-motivated with attention to detail and strong organizational skills
- Ability to successfully complete appropriate training requirements upon job assignment
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
- Experience working in an FDA or USDA regulated industry
- Excellent communication, organization, and leadership skills
- Strong interpersonal and team building skills
- Computer skills - Excel, Word, and PowerPoint
- Experience with document retention programs
- 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.
Notification of Drug testing and Background Checks
Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.
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