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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.
Provide routine Quality support at the Fort Dodge Hub Warehouse location. Scope of Quality support includes incoming inspection, material storage and handling, sampling and supplier quality. This position ensures all specifications are met prior to each stage of release to comply with Elanco and regulatory requirements.
Responsible for identifying quality risks and ensuring compliance with Elanco and regulatory requirements. Supports site supplier quality management program, including new supplier assessments, and quality agreements. Ensures maintenance of defined assessment frequencies for suppliers.
NOTE: This position is offering a $2,500 Sign-On Bonus!
Basic Minimum Qualifications:
High school Diploma/GED with 2-3 years of relevant experience OR Associate degree with 2 years relevant experience.
Work experience in USDA or regulated animal health industry is beneficial.
Advanced written communication skills, attention to detail, ability to follow written procedures, SOPs, specifications and other documents, and ability to perform basic mathematical calculations are required.
This position requires ability to utilize computer programs such as Microsoft suite, SAP, VEEVA, Success Factors and other relevant electronic applications.
Some lifting up to 30 lbs. may be required for handling of materials.
Basic understanding of QA Release processes within the area to assure departmental procedures are kept up to date with current practices and regulatory requirements, as well as leading/training others in basic job tasks and departmental improvements.
Audit preparation for regulatory agency audits/customer inspections and participation through demonstration of job tasks during inspections may be required as needed. Quality Competencies:
Analytical Thinking, Project/Program Management Planning and Organization – Demonstrating. Core Competencies: Communication, Problem Solving/Resolution, Business/Technical Knowledge, Delivering Results, Innovation and Change, Knowledge of Regulatory Requirements and Compliance.
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.
Perform sampling activities for materials
Perform inspection of sampled items against standards for conformance/acceptability
Logs samples into appropriate tracking systems until destruction date
Successful regulatory, third party and EGQCA audits/inspections
Effective execution of the Quality management system to identify and respond to product, compliance and quality system risks.
Ensures availability of released materials to production operations
Internal and Regulatory requirements are met for sample handling, storage and retention. Samples are representative, promptly submitted for testing if required to avoid product supply delays. Samples are accurately tracked through their shelf-life and stored according to requirements.
Incoming Quality Inspection:
Following appropriate sampling plan, pulls correct number of samples for inspection of each incoming serial/lot.
Utilize electronic comparator (TVS) or manual tools for inspection of items (raw material, printed component, etc) against standards/SOPs for conformance/acceptability.
Document results on inspection paperwork or electronically confirming acceptability of lot against local specifications.
Performs 2nd review/release approval of lots.
Initiates non-conformance reports for lots that do not meet requirements.
2nd review is performed in a timely manner. Errors are corrected prior to release.
The supervisor is immediately notified in the event of non-conformances so that immediate actions may be taken.
Deviations and CAPA:
Identifies issues and reports events per Elanco procedures.
Participates in investigation teams to identify root cause/CAPA.
Provides quality support to the hub warehouse operations regarding compliant documentation approaches involving deviations, CAPA and complaints.
Ensures prompt resolution of quality issues.
CAPAs are completed by target due dates.
Completes change control action items as assigned.
Revises existing procedures as changes occur.
Action items are completed by due dates. No delays in change control closure due to incomplete action items.
Revisions to documentation are timely and accurate to assure no delays in change control closure.
SAP and Material Control:
Performs movement transactions in SAP system of product
Performs usage decisions for batch release in SAP
Performs second check in SAP prior to batch release. Provides quality support of material handling, storage and control.
Movements/release transactions in SAP are performed in compliance with applicable SOPs.
Materials/product subject of a quality investigation are not moved without proper approvals to avoid their usage or release until the investigation has been completed.
Release transactions in SAP are accurate with no errors and are only performed after confirmation that all release requirements are met
Second review is performed in a timely manner. Errors are promptly corrected prior to batch release.
Ensures compliance with Elanco requirements for lot status assignment, inventory control and segregation and security of rejected material.
Executes supplier quality program: identifies compliance risks, develops risk mitigation strategies and ensures commitments are tracked and met.
Coordinates with EGQCA in the development of the annual supplier audit plan.
Conducts periodic reviews of supplier quality agreements.
Coordinates with procurement, R&D and site operations in the selection and approval of new suppliers
Requests and reviews supplier investigations in support of investigations into non-conforming materials.
Reviews supplier change notifications and performs impact assessments.
Maintains strategic partnership with suppliers and logistics providers
Ensures the quality of incoming materials, materials released are compliant to the approved specification.
Ensures requirements around testing for materials of animal origin are identified and implemented.
Ensures compliance with Elanco quality system requirements for training.
Completes own assigned training by target due dates
Identifies professional development opportunities for self and team.
Completes on the job training for each assigned job task.
Cross trains on other job tasks within department.
Trains other individuals within the department on specific tasks.
Performs training of other individuals within department per assigned training plans.
Willingly learns new tasks to support others during times of high batch volumes/workloads/staff shortages.
Participates in and may lead project teams as assigned by supervisor
Contributes to idea generation and solution development/process improvement.
Provides data to support implementation and suggests new ways to apply existing knowledge.
Displays respect and appreciation for individual differences; values contributions of others
Projects are completed by due dates
Primary work hours are first shift however, some overtime may be required due as business requirements change.
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