When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production.
How will you make an impact?
You should be practically and theoretically good in the field of expertise (Analytical methods). Knowledge of analytical methods and processes according to cGMP and EH&S guidelines and quality systems is achieved by keeping training status up to date and increasing own knowledge related to own activities.
What will you do?
- Executes sampling and testing of samples for the monitoring programs;
- Executes general QC-activities like clerical- and administrative tasks;
- Executes generic tests for cGMP projects, development, validation or stability programs;
- All activities must be executed in order to deliver the results in time and with the required quality;
- Organization of own operational activities in the QC laboratories according to the local EH&S and quality
- Contribute in the improvement of Quality Control procedures, quality and quantity of output;
- Contribute in the maintenance and continuous improvement of the procedures, techniques and equipment as used in the QC department;
- Execution of generic tests for monitoring activities, raw material testing, GMP- and PD projects in the
- (bio)chemical laboratory and the microbiological laboratory and execution of general QC activities;
- Train (new) colleagues in the relevant QC procedures and use of specific equipment;
- Support in validation, development and stability testing (generic tests);
- Write documentation for the work carried out for: generic analysis (analytical methods and equipment
- manuals), data logging (analytical protocols and logbooks) raw material testing (specification sheets and article information sheet), generic validations studies (e.g. PQ);
- Responsible as subject matter expert of assigned assays, and assures correct execution of testing according to procedures;
- Responsible for the proper functioning of specific equipment, as equipment owner expert user and/or trouble shooter, as agreed upon with the line manager. Execution of limited calibration and maintenance of equipment. Assure Equipment file is up to date with procedures, manuals and logbooks;
- Review of logbooks.
How will you get here?
- (K)MLO - laboratory education;
- Experience in analytical techniques in the bio(pharmaceutical) fields is desired.
Knowledge, Skills, Abilities
- Specific knowledge of biopharmaceutical analytical fields like biochemical, microbiological and physical/chemical methods and applications is desired
- Excellent knowledge and working in cGMP environment is desired.
- Verbal and written English at MLO level is required;
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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.