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Quality Systems Specialist - Lenexa, United States - CEVA Logistics
Description
The success of a company depends on the passionate people we partner with.Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked.
Yourmissions :
Job Summary and Purpose:
Quality Systems Specialists will maintain the quality functions associated with product deviation, investigations, CAPA's, Customer Complaints and quality production of animal health biological vaccines.
The Quality Systems Specialist will ensure all these functions are employed, utilized, monitored, and tracked consistent with Standard Operating Procedures and in compliance with regulations according to 9CFR and other individual country specific regulatory agencies.
This position supports the quality processes for work performed by CEVA, and its contractors, relative to vaccine development and licensure by USDA.
This position reports to the Quality Systems Supervisor.Responsibilities and Key Duties:
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Oversee the Deviation system including, number assignment, closing requirements, trending, and monitoring
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Lead teams, oversee, implement, and review Root Cause Analysis directed towards problems from deviations and other production floor assignments
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Oversee the CAPA system to ensure completion and monitoring of such
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Review, track, and resolve customer complaints that arise
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Adherence to all SOP's, procedures and documentation required to maintain and perform the above
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Ensure current on training required to perform the above
Additional Responsibilities:
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Performs other related duties as assigned.
Core Competencies
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Shape solutions out of complexity - Accepts needs for flexibility
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Client focus - Responds appropriately
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Collaborate with empathy - Responds to cooperation requests
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Engage and develop - Values learning for oneself and others
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Drive ambition and accountability - Shows concern for reaching targets
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Influence others - Communicates clearly
Technical / Functional Competencies:
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Decision Making - Make decisions that have impact to multiple tasks/departments
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Computer Skills - Ability to create and manipulate database/documents/spreadsheets to support business relatedreports
Collaboration /Teamwork - Displayed ability to build cross-functional teams that share information and achieve positive results throughout multiple departments and across multiple functions
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Science Application - Ability to proactively apply scientific concepts targeted towards continual process improvement
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Regulatory Knowledge – Experienced in compliance to 9CFR and other regulatory guideline documentation as required for the job duties
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Intermediate skills with databases and word processing programs, inventory management programs
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Understanding of root cause investigation, report writing and statistical analysis
Qualifications:
Education:
Bachelor's degree in Biology or related subject
Work Experience:
Two years in veterinary biologics, pharmaceutical, or medical devices industry. Have a working knowledge of 9CFR and APHIS regulations. Must have working knowledge of quality systems including document control, deviations, change control and internal auditing.
Physical Requirements:
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Position will require bending, twisting, lifting, and standing.
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Ability to walk between different areas and buildings.
Working Conditions:
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Position is located at the Ceva Animal Health Lenexa campus
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Will be moving from multiple buildings on campus.
Travel Required:
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If travel required, it will be minimal
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job.
This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job.
This job description is not an employment contract.Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
*VEVRAA FederalContractor**Ceva is an equal opportunityemployer and all qualified applicants will be considered for employment withoutregard to race, color, religion, sex, national origin, age, geneticinformation, actual or perceived sexual orientation, gender identity, disabilitystatus, protected veteran status, or any other characteristic protected bylaw. Ceva encourages men and women, members of all racial and ethnic groups,individuals with disabilities and veterans to apply.
669B
Yourprofile :
Education:
Bachelor's degree in Biology or related subject
Work Experience:
Two years in veterinary biologics, pharmaceutical, or medical devices industry. Have a working knowledge of 9CFR and APHIS regulations. Must have working knowledge of quality systems including document control, deviations, change control and internal auditing.
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