QA Specialist (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

* 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

* 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 within their area of operation

* Knowledge of continuous improvement tools and investigation tools in order to propose solutions

* Knowledge of the specific technical standards, guidelines and tools

* Capability to challenge counterparts and adapt solutions

* Knowledge of quality systems tools and how to apply them covering the streams requested by the main global regulations

* Strong written and verbal communication skills

* Ability to organize and prioritize multiple tasks

* Working knowledge of Microsoft Office suite, and other common computer applications

* Demonstrated understanding of the quality impact on production

* Strong analytical skills

* Attention to detail with respect to documentation, communication, and organization

* Ability to effectively solve problems and issues without a lot of direction from above

* Self-starter - must be willing and able to take initiative to continuously improve processes and procedures

Education - Bachelor's degree in a science related field

Work Experience - Five years' experience in a regulated, biotechnology or pharmaceutical industry. Must have a working knowledge of quality systems.

Two years of experience leading investigations, deviations, CAPAs, and Change Controls, preferred

Other (consider certifications, specialized knowledge and/or training, etc.) - N/A

* Ability to read, write legibly and communicate in English

* Tasks frequently require prolonged, mental, and visual concentration

* Position will require bending, twisting, lifting, standing, walking, and sitting

* Clean room manufacturing laboratory setting as needed

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

**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

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