Quality Assurance Specialist II (Night Shift 6 PM - 6 AM) C Shift in Lodi, CaliforniaAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
The Quality Systems Specialist is responsible for reviewing records to comply with QSR and ISO requirements. They make recommendations for improvement and create training materials and operating manuals. This person is involved with various quality continuous improvement activities.
This position is part of the Quality Systems Specialist II team and will be located in Lodi, CA.
In this role, you will have the opportunity to:
Collaborate with the manufacturing department for scheduling line clearance and line setup activities.Review records, documents, and eDMS electronic documentation for completeness and compliance with QSR and ISO requirements.Generate standard operating procedures to define and improve quality system functions.Support the Material Review Board for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.Lead and participate in interdepartmental initiatives for continuous improvement.The essential requirements of the job include:
High school diploma (or equivalent experience) with 2-4 years of relevant experience in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience ORAA or Technical Trade Degree with 1-2 years of work experience.Must be familiar with ISO standards and applicable regulatory requirements (CE/FDA/QSR) and GDP.It would be a plus if you also possess previous experience in:
Experience in DNA diagnostics or other medical devices.Ability to interface well with people of varied backgrounds and to guide groups toward effective dynamics.This position requires a 12-hour shift (6 pm - 6 am) with an alternating 3-day/4-day work schedule.
Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.
The salary range for this role is $25.38 - $33.65. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
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