QA Technician I (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 shipment. This position will also support and assist with the day-to-day administration of the company's quality systems and document control programs.

* Review records and data for accuracy and adherence to internal procedures, good manufacturing practices, and regulatory requirements; using a guided processes for direction

* Conduct authorized sampling of final products

* Schedule and coordinate processing of final product samples for shipment

* Maintain inventory of final product retention samples and final product stability samples

* Understand and apply the Quality Management System (QMS) procedures and policies

* Issue records for process execution

* Perform release of inbound materials and in-process materials using the guided process

* Record and track data for trending and/or evaluation

* Update and maintain tracking log systems

* Assist with the administration of quality documents and the document control system

* Assist with the organization and maintenance of quality department files

* Explain and role model the expected 'quality behaviors' on the shopfloor

* Solutions out of complexity - Work to evolve immediate environment

* Client focus - Make sure needs and requests are treated equally and in a positive way

* Collaborate with empathy - Fully takes part in the working group to share information, listens to others and have a clear idea of the decisions made

* Engage and develop - Open to share knowledge and to receive feedback from others

* Drive ambition and accountability - Ensure accuracy of work with the use of KPI's and a responsible commitment

* Influence others - Show confidence while speaking

* Basic knowledge and understanding of Ceva's organization, products and processes

* Basic knowledge of continuous improvement tools and investigation tools with the capability to identify issues

* Knowledge of the specific technical standards, guidelines and tools

* Capability to analyze issues and propose solutions

* Demonstrated understanding of the quality impact on production

* Strong analytical skills

* Strong sense of teamwork with respect to working with other stakeholders, internal and external

* Must be able to become gown certified for entry into aseptic processing laboratories

* Thorough attention to detail with respect to documentation, communication and organization

* Strong communication skills, both written and verbal

* Flexibility to work overtime as needed, or outside of normal business hours, which may include weekends and holidays

* Able to work under time constraints and deadlines

* Working knowledge of Microsoft Office

* Basic data entry skills

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

Education - Bachelor's degree in biological science or Quality Management System (QMS), preferred, or Associates degree plus equivalent work experience

Work Experience - Minimum of one year of experience, preferred or demonstrated competency in a regulated biotech, or pharmaceutical industry environment. Experience with record and document auditing, preferred

* Ability to read, write legibly and communicate in English

* Tasks frequently require prolonged, mental, and visual concentration

* Able to sit or stand for long periods of time

* Office space

* Clean room manufacturing laboratory

* N/A

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.

669B

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