QA Engineer I

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

REQUIREMENTS:

Location/Division Specific Information 

The Thermo Fisher Scientific site in Naarden develops and produces innovative affinity resins used in cGMP manufacturing by our customers. The QA department is responsible for the Quality Management System of the site and the quality aspects of the products produced at the site. QA participates in customer projects to develop customer specific affinity resins.  

 To execute and support all these activities, we are looking for a QA Engineer I, who is able to carry out the activities according to the latest knowledge and quality management principles. The QA Engineer I works in close collaboration with all the other functions involved in the development and manufacturing of products. The QA Engineer I will be involved in the execution of a wide range of different QA activities.

The QA Engineer I should be able to plan, monitor, execute and report the required activities with limited support of the supervisor.  

 Responsibilities: 

• Maintain and continuously improve the Quality Management System;

• Review batch records, generate Certificates of Analysis and release products to the market;

• Register and review root cause investigations of deviations or complaints in our TrackWise Quality Management System;

• Understanding and prioritizing customer needs during problem solving initiatives, improving efficiencies and customer satisfaction;

• Answering customer questions regarding our products.

Education 

• HBO in Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field.
• with > 3 years Quality Assurance experience, or Master of Science; or through relevant experience and experience in the Quality Assurance area.  

Experience 

• Experience in Quality Management Systems in a ISO9001 or GMP environment;

• Experience in a Document Management System;

• Experience user of Quality Management System software, such as TrackWise.

Knowledge, Skills, Abilities 

• Verbal and written English at HBO/Scientific level; 

• Good knowledge and working according to quality standards as cGLP, GMP or ISO9001; 

• Good social and communication skills; 

• Good planning and organizational skills;
• Ability to work independently and collaborate effectively with cross-functional teams;

• Ability to challenge existing approaches to compliance in order to seek improved ways of working; 

• Excellent judgement and creative problem-solving skills.

What we offer

At Thermo Fisher Scientific, you’ll work in a welcoming, open, and safe environment where collaboration and personal growth are encouraged. We offer training and career development opportunities, with plenty of possibilities to grow both horizontally and vertically within the organization.

You’ll also benefit from competitive benefits and flexible working hours. While this is primarily an on-site role, we offer flexibility to work from home in agreement with the QA supervisor, supporting a healthy work-life balance while you build a career that grows with you.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.  

Apply today! http://jobs.thermofisher.com 

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.