Location: Bothell,WA, USA
At 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 worlds 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.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, were working at the pace of change on diagnostic tools that address the worlds biggest health challenges, driven by knowing that behind every test there is a patient waiting.
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We are currently seeking a Calibration Specialist who will be responsible for managing the calibration program for Manufacturing, QC and R&D. The Calibration Specialist is responsible to ensure all equipment calibrations are performed per requirements for the Cepheid Bothell campus. This position is in the Quality department and will contribute to improvements in compliance to FDAs Quality System Regulation and ISO 13485 Standard. This position will make significant impact to the Bothell site by supporting facility growth and implementing improvements to increase efficiency, delivery, and consistency of calibration program.
At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
+ Ensure calibration schedule adherence to meet cGMP compliance, production and R&D requirements. Communicate calibration due dates to equipment owners.
+ Schedule on-site calibration events and coordinate off-site calibrations with equipment owners and external service providers to minimize down time.
+ Provide training to equipment owners and visiting service providers.
+ Investigate equipment out of tolerance events.
+ Maintain calibration records in the asset management system, hard copy records management, and prepare reports and metrics.
The essential requirements of the job include:
+ Bachelors degree in life science discipline
+ Minimum of 0 2 years relevant work experience
+ Prior science or chemistry knowledge to apply understanding of laboratory equipment.
+ Conceptual knowledge of practices and procedures within a regulated industry to ensure GDP/GMP and compliance.
+ Demonstrated excellent time management skills, attention to detail, and effective communication across functions and with external service providers.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to work in office and laboratory environments
+ Must be able to lift 30 lbs. Must be able to stand for several hours.
It would be a plus if you also possess previous experience in:
+ Medical Device with ISO 13485:2016 standards, FDA GMP regulations, or healthcare experience.
+ Using calibrated equipment
+ Chemistry production or analytical work (especially oligonucleotide chemistry)
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
The salary range for this role is $70k - $88k 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 comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law.
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Join our winning team today. Together, well accelerate the real-life impact of tomorrows 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.
For more information, visit www.danaher.com .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at ...@danaher.com to request accommodation.
Operating Company: Cepheid