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?
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;
Supports investigations related to OOS results and deviations and other Quality System activities;
Contributes to the operational planning and subsequent execution of project related experimental activities in consultation with the Labhead QC;
Act as owner and/or subject matter expert for assigned equipment and assays and related procedures.
What will you do?
- Independent execution of 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 to line manager and/or Quality Control Scientist. Related documentation has to be of high quality;
- Acts as Quality Control project lead for customer work plans in the laboratory, for the assigned Quality Control technicians to support testing (functional supervision);
- Timely determines needs for raw materials for project activities and orders in consultation with the Quality Control Scientist;
- Support Scientist with set up, organization and execution of the (experimental) project planning;
- Produce accurate assay specific Quality Control planning for assigned projects;
- Assists Quality Control Scientist team by both proposing and challenging the intended experimental set-up of assigned (technically complex) project related activities in the Quality Control laboratories in order to meet the customer’s requirements and needs;
- Support the implementation of new techniques based on client requirements or internal technology innovation;
- 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. URS, IOQ,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. URS, IOQ, PQ’s), development studies (work plan and summary reports), spread sheets, forms (test application report form), deviation report, out of specification;
- Able to support complex 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 and users and Labhead QC;
- Executes general QC-activities like clerical- and administrative tasks;
- Able to present Quality Control related topics to the Quality Control department and other departments, (presentations);
- 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;
- Review of logbooks.
How will you get here?
- HBO / Bsc.with > 5 years Quality Control experience, or Master of Science (in (micro)biology, biochemistry, chemistry);
- Experience in the analytical area of the bio(pharmaceutical) field;
Knowledge, Skills, Abilities
- Knowledge of quality systems in the regulated industry, specifically in cGMP
- Verbal and written English at HBO/Scientific level is required;
- Good social and communication skills;
- Affinity with: HPLC, UPLC, cIEF, CE-sds, EMPOWER software, Mass spectrophotometry
- Planning skills.
- Problem analysis;
- Communication (oral and written);
- Progress monitoring;
- Planning and organization;
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.