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QA Release Officer in Medemblik, Netherlands at Pall

Date Posted: 3/13/2019

Job Snapshot

Job Description

Job ID: LIF004118

About Us

Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.

Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.

Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.

Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.

To learn more about Pall, please visit https://www.pall.com/en/about-pall.html.



Description

Goal of the position:

In this role you are part of the Quality Assurance team and mainly responsible for the batch record review and final product release and certification. Another part of the job is related to the maintenance of quality data, creation of sample plans and the support of other routine Quality Assurance tasks.

Responsibilities:

  • Review batch documentation records to ensure goods are being released in compliance with the current specifications and internal procedures in a timely and thorough manner;   
  • Review Certificates of Sterility / Irradiation  to ensure that goods are treated according to the validated settings;
  • Review customer facing documents to assure GMP compliance;
  • Data analysis and implementation of continuous improvement plans to meet agreed KPI's;
  • Certify finished goods for release to customer;
  • Initiate Supporting activities for GDP and RFT actions;
  • Reject non conform goods according to current procedure;
  • Support quality investigations of cGMP products as required;
  • Perform internal auditing and quality inspections routinely on the shop floor as preventive measure;
  • Coordinate, maintain and participate in the Kamishibai auditing system at Gemba related to quality aspects;
  • Identify, investigate and prepare reports on quality issues;
  • initiate and follow-up on CAPA's related to Internal Deviations;
  • Support in GMP / GDP Training and awareness programs;
  • Use of day-to-day risk-based approach;
  • Support customer audits regarding questions related to batch release;
  • Maintain effective communication and partnership with other departments.

Job Requirements



Qualifications

Education, Skills & Experience:

  • Junior Bachelor’s degree in a scientific field, preferably in Life Sciences (bio,biomedical, chemical, pharma,…) or similar through experience;
  • Good analytical skills and knowledge of problem solving techniques;
  • Is aware of and appropriately uses DBS tools;
  • Is engaged and supportive of continuous improvement;
  • Team player with speak up mentality;
  • Ability to work both independently and with a team in a collaborative setting;
  • Fluent in English and Dutch (both oral and in writing);
  • Familiar with Microsoft Office;
  • Customer first mindset;
  • Knowledge of Six Sigma tools and SAP is an asset;
  • Knowledge of quality standards (e.g. ISO 9001 is an asset);
  • Excellent organizational skills along with strong attention to detail and time management.


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.