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.

• Oversee the Deviation system including, number assignment, closing requirements, trending, and monitoring

• Lead teams, oversee, implement, and review Root Cause Analysis directed towards problems from deviations and other production floor assignments

• Oversee the CAPA system to ensure completion and monitoring of such

• Review, track, and resolve customer complaints that arise

• Adherence to all SOP’s, procedures and documentation required to maintain and perform the above

• Ensure current on training required to perform the above

Additional Responsibilities:

• Performs other related duties as assigned.

• Shape solutions out of complexity - Accepts needs for flexibility

• Client focus - Responds appropriately

• Collaborate with empathy - Responds to cooperation requests

• Engage and develop - Values learning for oneself and others

• Drive ambition and accountability - Shows concern for reaching targets

• Influence others - Communicates clearly

• Decision Making - Make decisions that have impact to multiple tasks/departments

• Computer Skills - Ability to create and manipulate database/documents/spreadsheets to support business related reports

• Problem Solving: Ability to consistently perform and deliver lasting results within ambiguous situations

• Collaboration /Teamwork - Displayed ability to build cross-functional teams that share information and achieve positive results throughout multiple departments and across multiple functions

• Science Application - Ability to proactively apply scientific concepts targeted towards continual process improvement

• Regulatory Knowledge – Experienced in compliance to 9CFR and other regulatory guideline documentation as required for the job duties

• Intermediate skills with databases and word processing programs, inventory management programs

• Understanding of root cause investigation, report writing and statistical analysis

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.

• Position will require bending, twisting, lifting, and standing.

• Ability to walk between different areas and buildings.

• Position is located at the Ceva Animal Health Lenexa campus

• Will be moving from multiple buildings on campus.

• 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 Federal Contractor