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.
Supports investigations related to OOS results and deviations and other Quality system related activities;
Act as owner and/or subject matter expert for assigned equipment and assays and related procedures;
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 guidelines;
Contribute in the improvement of QC procedures, quality and quantity of output.
What will you do?
- Execute routine testing activities(cGMP projects, development, validation or stability programs) and testing activities for customer projects, in the Quality Control department according to procedures and work plans, local EH&S and quality guidelines;
- 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, if assigned;
- Organization of own operational routine testing and independent execution of project related experiments according to approved procedures, work plans, local EH&S and quality requirements;
- Interpret and report the results of the work carried out in report format (if requested) and timely (verbal) updates Labhead QC and Quality Control Scientist. Related documentation has to be of good quality;
- Timely determines needs for raw materials for project activities and orders in consultation with Quality Control Scientist;
- Contributes to implementation and understanding new process techniques based on client requirements or internal technology;
- 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) validation studies (E.g. PQ’s), development studies (work plan and summary reports);
- Review, data interpretation of the work carried out in written form: analytical protocols, analytical methods, validation studies (e.g. PQ’s), development studies (work plan and summary reports), spread sheets, forms (test application report form), deviation report, out of specification, and logbooks;
- Able to support investigations related to OOS results and deviations, and able to write Change requests;
- Delegated responsibilities of Labhead QC, if assigned;
- 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;
- Supports in the maintenance and continuous improvement of the procedures, techniques and equipment as used in the Quality Control department;
- Actively pursue potential improvements of the Quality Control quality system and revise Quality Control documentation in consultation with other document owners, users and Labhead QC;
- Executes general QC-activities like clerical- and administrative tasks;
- Participates in audits as a subject matter expert on tasks/assays assigned;
- Responsible for being fully trained in specific assays / work plan, before execution of the assay/ work plan;
- Contributes to the training of (new) colleagues in the Quality Control department.
How will you get here?
- MBO with several years of relevant experience or HBO / Bsc. level. (in (micro)biology, biochemistry, chemistry);
- 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.
- Relevant work experience with Elisa.
- Verbal and written English at HBO level is required;
- Organization of own work;
- Ability to learn;
- Result orientation;
- Quality orientation;
- Problem analysis/ Judgment
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.