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Document Controller Quality Assurance - Temporary role in Amsterdam, Netherlands at Leica Biosystems

Date Posted: 1/31/2019

Job Snapshot

Job Description

Job ID: LEI004684

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.


Description

Position Summary

This is a temporary 8-10 months contract position to cover maternity leave in the Quality Department.

The incumbent is expected:

  • to follow existing policies, procedures and work instructions to plan and conduct tasks.
  • to follow instruction and guidance from Sr. QA Officer.
  • to have experience in document management, preferably within QA/QC function in medical devices or pharma company.

Training in local procedures will be provided.

Depending on previous experience, a higher level of responsibilities / duties can be assigned

Major Responsibilities

  • Maintain QA/QC Documentation ensuring the timely follow up of requests and approval of controlled documents, and accuracy of records.
  • Review all submitted documents for accuracy and completeness, adjust any formatting errors, typos and spelling errors prior to submission for approval.
  • Follow Good Documentation Practice to maintain Quality System documentation process in good order.
  • Use available communication methods to follow up on issues with respect to missing/ incomplete documents resulting in reviews, approvals, or signatures.
  • Review documents, such as product records, quality specifications, test methods, documented procedures, written instructions, etc., as required.
  • Process and maintain records for changes, non-conformances, CAPAs, batch production, etc. following the established processes.
  • Maintain paper and digital archives.
  • Perform other departmental tasks as assigned.


Job Requirements



Qualifications

Required skills/Experience:

  • Work experience in administering, managing, maintaining documentation.
  • Proficiency in Microsoft Office applications.
  • Good level of English - spoken and written.

Desirable

  • Work experience in a Quality Control or Quality Assurance environment.
  • Experience of working to a recognised Quality Management System (e.g. ISO9001 / ISO 13485) and following quality procedures including Good Documentation Practises.

Competencies

  • Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports. 
  • Ability to detect problems and analyze data.
  • Strong organizational skills. 
  • Ability to multitask.
  • High level of integrity

To Apply:
Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities.  As a Leica Biosystems employee you will be consistently challenged to deliver your best. 
If you are ready for this challenge, submit your resume for consideration.  http://www.leicabiosystems.com/about/careers/
Be sure to follow Leica Biosystems on LinkedIn!


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.