QA Specialist; Verona, WI

Overview

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.

Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a a "One Health" approach. Ceva Animal Health is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants.

To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Your Missions

Location:

Verona, WI

Responsible for assuring the consistent quality of products and services by examining and reporting on the adequacy and/or deficiencies associated with documentation created during manufacturing and testing activities from receipt of inbound materials to final product release. This position will also maintain the administration of the company’s quality systems and document control programs, as well as master and working seed and cell lines for the manufacture of animal health biological vaccines.

Leadership/Collaboration

• Must work with staff from multiple departments during review, correction, and finalization of documentation
• Must be able to work with staff from multiple departments to lead effective investigations
• Responsible to work with other groups to identify needed changes in documents or improvements in documentation
• Provide guidance for all day-to-day operations of Quality Management Systems (QMS)
• Assist with training, mentoring and developing QA staff

Quality

• Responsible for review of production, testing, and shipping records for completeness and accuracy. Determines suitability of approval and release of product orders
• Responsible for review of incoming raw material documentation to ensure they meet required specifications
• Assist with updates to the Standard Operating Procedures and Validation Documentation
• Control and maintain accurate accounting of inventory and proper authorization of release for all master and working seeds and cells
• Utilize JD Edwards (JDE) computer system to set appropriate disposition of materials and product
• Responsible for the application, maintenance, and ownership of the QMS procedures and policies
• Responsible for issuance of documents to production
• Conduct audits of activities/projects as appropriate and act as lead auditor for complex/external audits
• Drives and participates in continuous improvement of the QMS
• Lead the documentation and sample storage efforts
• Follow trends as indicators of performance of QA and production and assist in developing improvement ideas as required

Delivery

• Author, review, and approve deviations, change control, CAPA, SOPs and other QMS documents as needed
• Lead deviation investigations and effectively determine CAPAs
• Responsible for maintenance of product tracking databases
• Assist in the reporting of departmental and site KPIs
• Train others as required

Core Competencies

• Shape solutions out of complexity - Is open and curious of others’ perspectives
• Client focus - Has in mind client’s satisfaction
• Collaborate with empathy - Has a positive attitude towards collaboration
• Engage and develop - Clarifies short and long-term directions
• Drive ambition and accountability - Proactively manages own and others’ work
• Influence others - Communicates transparently

Technical / Functional Competencies

• Ability to lead an audit with relevant time management, investigation posture, adaptability approach, and interpersonal relationship skills in various fields
• Advanced knowledge and understanding of Ceva's organization, products and processes…