The QA Specialist is responsible for promoting Quality and Right First Time on the production floor. The QA Specialist helps production staff with correct documentation, quality decisions during production, being available to production staff for questions and training, assisting with investigations and closing deviations, conducting Gemba walks to assist in root cause determinations and assisting in audits.

• Must work with staff across multiple departments, particularly in the production setting.

• Observe production activities, for example CEF preparation, antigen harvest, batching, cleaning, media fills, etc

• Review production records, inventory records and product transfer processes and assist production staff in correcting documentation concurrently, and documenting production appropriately.

• Audit raw materials and logs including, consumables expiry, temperature monitoring, equipment monitoring and maintenance, and confirm QA release on incoming raw materials into production

• Providing input on Quality decisions to the production team and assist with training, particularly regarding documentation, aseptic technique, and recording events.

• Responsible for go-sees and Gemba walks as needed to collect more information for events/deviations, investigations and root cause determinations. Aids in the development of appropriate CAPA.

• Assist with review of and writing of documents such as investigations, validation, SOPs, Outlines and production records.

• Create, revise, verify and approve SOP’s, Production Outlines, Special Outlines, and other Quality documentation

• May fill in as needed for other QA areas, as needed.

• Shape solutions out of complexity - Is open and curious of others perspectives

• Client focus - Has in mind clients satisfaction

• Collaborate with empathy - Has a positive attitude towards collaboration

• Engage and develop - Clarifies short-term directions

• Drive ambition and accountability - Proactively manages own and others work

• Influence others - Communicates transparently

• Strong interpersonal communication skills with all levels of management from production floor to senior management

• Exceptional attention to detail and ability to maintain consistency

• Strong organizational skills; able to effectively manage more than one priority and/or project at once

• Excellent communication skills, both written and verbal

• Proficiency in and knowledge of Microsoft Office Suite, Google Suite and other common computer applications

• Ability to work independently, with minimal supervision while adhering to deadlines

• Ability to perform data analysis, understanding technical data and to problem solve

• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary, this may include weekends as required

Education - B.S. degree in a science related field (or relevant experience) preferred

Work Experience – 3-5 years of experience in quality assurance roles, within a biologics manufacturing environment, preferred. Experience working with records and document auditing is preferred.

Other – Knowledge of familiarity with quality systems and production of vaccines

• Able to read, write legibly and communicate in English

• Able to stand for extended periods in a production environment

N/A

Between facilities in the KC campus

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.