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 Specialist coordinates and conducts activities of the Quality Assurance Department regarding the receipt of materials for use in the manufacturing process in accordance with USDA regulations and samples submissions. 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 Regulatory Affairs, Registrations, Distribution and Customer Service Departments.
- Performs quality review and release of raw materials received by the site.
- Collects, confirms tests, submits to laboratory for CFR conformance for animal origin. Retains off test reports for audit purposes.
- Responsible for physically releasing final product for sale upon receipt of the USDA signed Form 2008 as well as placing questionable material on hold or in segregation.
- Participates in inventory reconciliation. Archiving of records and files.
- Compiles and reviews data for submission on APHIS Form 2008s and submits requests for release of product to the USDA.
- Collects, records, and submits samples for all final product serials and other USDA requests. Maintains all plant and APHIS retention samples. Manages all retention samples following Elanco standards for inventory and purging.
- Issues out of stock, collects and labels all nonroutine samples such as retesting samples retaining records of requests.
- Maintains electronic and paper files of Certificates of Analysis, Certificate of Origin and Ingredients of Animal Original for all raw materials and goods utilized in the production of final product and antigen in accordance with 9CFR.
- Creates and updates Raw Materials Specification sheets for all raw materials used for the manufacture of product or involved with the testing of final product manufactured by Elanco.
- Communicates product quality problems received by Labeling, Packaging, Inventory Control personnel to the Supply Chain Manager, Distribution Section Leader and Quality Assurance Manager; recommends corrective action and specifies follow up procedures, if necessary.
- Works closely with the QA Manager and QA Specialists in the investigation and disposition of Customer Complaints, Process Deviation(s), QA holds, Stop Sale(s), Product Recall(s), and Return Authorization procedures.
- Reviews, writes, and manages Quality Agreements with vendors and coordinates with EGQS for audits of vendors annually.
- Writes, reviews, and maintains Standard Operating Procedures for the QA Department.
- Conducts USDA Sampler Training.
- Writes, reviews and manages protocols as needed concerning final product.
- Organizes and conducts specific training programs and quality workshops as they pertain to QA’s role in distribution.
- Assists the Quality Assurance Associates and Quality Assurance Manager as needed.
- High school diploma or GED
- A minimum of one year of direct experience in a regulated (USDA, FDA, ISO etc.) manufacturing environment.
- Have working knowledge of SOP’s and experience in compliance to governmental regulations (USDA and/or FDA).
- Possess advanced oral and written communication skills.
- Being adept at always communicating with tact and professionalism, internally and externally, while fostering mutually beneficial results.
- Above average organizational skills and exceptional attention to detail.
- This is a first shift role (Monday to Friday)
- Paid overtime may be required
- Must not have contact with avian species (birds) at home due to the nature of the manufacturing
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