Document Control Quality Systems Specialist III in Sunnyvale, California at Cepheid

Date Posted: 10/26/2018

Job Snapshot

Job Description

Job ID: CEP002371

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

  • POSITION SUMMARY:
    This position is responsible for general support, maintenance and execution of processes and activities associated with the Document Control Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485. Specifically, change management, document control and records review functions are included under this position.

    ESSENTIAL JOB RESPONSIBILITIES:
    • Perform Change Analyst activities involving preparation, review, routing, release and implementation of change orders and affected part and document items in Agile PLM system.
    • Maintain a multi-site Master Change Approval Matrix.
    • Provide group training and real-time assistance in the use and operation of Agile PLM system and change control procedures.
    • Execute various queries, periodic reviews and reports related to the status of documents and changes.
    • Facilitate process improvement cross-functionally through training, coaching and team participation.
    • Collect, process, monitor, maintain and report quantitative and qualitative metrics related to effectiveness and efficiency of change management processes and progress toward defined quality goals.
    • Lead and participate in interdepartmental initiatives for continuous improvement of procedures, processes and systems.
    • Support business systems validations, internal audit activities, PLM system administration.
    • Review records and documents for completeness and compliance with GDP, QSR, ISO requirements and internal organizational procedures.
    • Review batch records to support release of raw materials, work in progress and final products including reagents, components and instrumentation-related products. 

Job Requirements



Qualifications

  • MINIMUM REQUIREMENTS:

    Education or Experience (in years):
    • A minimum of 8 years’ experience with a Bachelor's degree or 10 years with Associates degree in information, computer, quality, engineering or related discipline or equivalent practical experience in a regulated medical device, pharmaceutical or life sciences product manufacturing environment.

    Knowledge and skills:
    • Excellent verbal and written communication skills are a must; in group or one-on-one settings.
    • Basic familiarity with technical specificatios, mechanical and electrical part CAD drawings.
    • Excellent computer system skills and knowledge of Microsoft Word, Excel, Powerpoint, EDMS/PLM (e.g. Agile PLM, Documentum ECM, Veeva CM) and ERP (e.g. SAP) software applications.
    • Ability to interface well with people of varied backgrounds and to guide groups toward effective dynamics.
    • Understanding of general mathematical principles and calculations, at college entry level.
    • Ability to perform routine statistical applications.
    • Experience in compiling data to support metrics analyzing current process.
    • Basic understanding of ISO 13485 and 21 CFR Part 820.

    Physical requirements/abilities:
    • Ability to work in an office environment.

    PREFERRED REQUIREMENTS:
    • Agile PLM
    • Change Analyst or Change Control Board facilitator
    • Experience with DNA diagnostics or other medical devices.

    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.