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Quality Systems Specialist in Bothell, Washington at Cepheid

Date Posted: 11/19/2018

Job Snapshot

Job Description

Job ID: CEP002460

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

Cepheid is seeking a Quality Systems Specialist responsible for strengthening compliance and improving the Quality Management System processes at the Cepheid Bothell facility by employing best practices to ensure compliance to applicable Medical Device regulations (QSR) and standards (ISO) and Cepheid Corporate Quality Policies. The Quality Systems Specialist's functions include material and product review and release, records management, change control and deviations evaluations, qualification and validation reviews.

Primary Responsibilities

•Release raw materials.
•Review production batch records, QC test results and release product.
•Records management; includes filing, logging, tracking, laboratory notebook issuance and other duties associated with record storage and archiving.
•Audit equipment documentation; includes log books and calibration and maintenance activities in asset management database.
•Review records and documents for completeness and compliance with company policies and procedures.
•Review change controls, deviations and CAPAs and maintain tracking system to ensure timely closure.
•Support training activities for company personnel and third party vendors.
•Support validation activities for products, processes, equipment and facilities. This includes review of protocols, protocol execution, deviation investigation and resolution, test results and reports.
•Partner with company associates to strengthen compliance. Facilitate and assist with initiatives for continuous improvement.

Job Requirements



Qualifications

Qualifications

Education and Experience:

•Bachelor’s Degree in scientific discipline or equivalent combination of education and experience in a regulated manufacturing environment to perform at this level.
•Minimum of two years quality assurance experience in a regulated manufacturing environment.

Knowledge and skills:

•Strong documentation and report writing skills.
•Excellent verbal and written communication skills in-group and one-on-one settings.
•Ability to partner well in a diverse environment.
•Exceptionally strong organization, accuracy, and attention to detail skills required.
•Computer skills: Microsoft Office with strong Excel and Access skills.

Preferred experience, knowledge and skills:

•Medical device manufacturing or quality experience preferred
•Chemistry, biochemistry or DNA diagnostics experience preferred
•Experience with qualified equipment preferred
•Experience with electronic document management, quality management, training management and/or equipment management systems preferred.

Physical requirements/abilities:

•Ability to work in an office environment
•Ability to lift boxes up to 30 lbs
•Ability to be in laboratory environments

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.