QC Lab Technician II (Verona, Wisconsin)

Responsible for performing a variety of Quality Control (QC) testing procedures to verify the safety, purity, and composition of in-process and finished products prior to use, sale, or distribution. Provide technical support, and contribute to method optimization, ensuring compliance with regulatory standards and internal quality systems.

• Maintain the Quality Control Suite of laboratories in a clean and orderly state at all times

• Independently perform Quality Control testing methods and general laboratory duties in compliance with approved SOPs

• Provide training, guidance, and mentorship to new or less experienced QC employees

• Coordinate daily testing schedules and workloads to ensure timely completion of QC activities

• Assist in troubleshooting and optimizing test methods; support validation and transfer activities as needed

• Review and update methods and documentation to maintain compliance with 9CFR and other applicable regulations

• Conduct periodic document and record reviews within the QC department and perform document updates as required.

• Prepare and maintain necessary media, reagents, and solutions for laboratory use

• Perform microbiological and chemistry tests such as cell culture, spectrophotometry, sterility, mycoplasma, PCR, ELISA, gram stain, pH, and egg titer assays

• Document daily facility and equipment observations; submit maintenance requests as appropriate

• Support continuous improvement activities and participate in cross-functional initiatives

• Perform other related duties as assigned

• 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 responsible commitment

• Influence others - Show structure and confidence while speaking

• Ability to assist and observe during audits and inspections

• Basic knowledge of pharmaceutical development, regulatory and manufacturing sciences

• Ability to understand Ceva's organization, products and processes

• Knowledge of and ability to apply continuous improvement and root-cause investigation tools to identify and resolve issues

• Knowledge of specific technical standards, guidelines and tools

• Demonstrate ability to analyze complex issues and implement practical solutions

• Working knowledge of Microsoft Office

• Advanced understanding of quality systems and ability to apply GLP, GCP, and GMP principles in daily work

• Demonstrated understanding of the quality impact on production

• Strong analytical skills

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

• Strong communication skills, both written and verbal

• Able to work under time constraints and deadlines

• Strong teamwork and cross-functional collaboration skills, with ability to train and mentor others

Education – Undergraduate degree in Biology, Chemistry, or a related scientific discipline preferred, or Associate’s degree plus equivalent work experience.

Work Experience – Minimum two (2) years’ experience in Quality Control or relevant laboratory experience. Experience with cell culture or microbiological methods preferred.

• Ability to read, write legibly and communicate in English

• Tasks frequently require prolonged, mental, and visual concentration

• Able to lift up to 25 lbs on a regular basis and 50 lbs on a periodic basis

• Able to sit or stand for long periods of time

• 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.

**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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