Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly-established GMP laboratory for production of pluripotent stem cell lines. For more information, visit our website: www.takarabio.com
The company is now looking for the following competence.
Quality Control Associate
The Quality function assures that we meet safety, quality, identity and purity requirements for our products and services. The QC Associate plays an important role by supporting the business in delivering and improving products and services to meet regulatory requirements and the needs of our customers.
As a member of the Quality team, the QC Associate will work hands-on on quality control related tasks for both our research-grade products and in our new GMP facility to ensure that work is consistent with the overall strategic direction of Takara Bio Europe AB. This is accomplished through close collaboration with team members and the organization.
Primary Duties & Responsibilities
- Responsible for environmental control of clean room areas in the GMP facility.
- Quality control of non-GMP stem cell related products and services.
- Take part in general maintenance activities in the clean room area.
- Receiving materials and approving them for use.
- Follow Quality Management System processes and procedures.
- Develop Quality System processes, i.e. writing and reviewing SOPs within the QC area.
- Issue, review and assess QC batch related documentation and environmental control documentation.
- Issue deviations related to Quality control to identify root cause, corrective and preventive actions.
- Participate in qualification and validation activities in QC equipment and systems.
- Train employees in relevant QC areas.
- When needed take part in Quality related Risk Assessments as a QC-function representative.
- When needed take part in audits and regulatory inspections.
- Normally receives no instructions for routine work, general instructions on new assignments.
General Duties & Responsibilities
- Exhibit general knowledge of professional ethics, laws and regulations.
- Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP).
- Relies on instructions and pre-established guidelines to perform the job.
- Work during weekends may be a temporary requirement.
- Other required duties may be assigned.
Education Requirement (minimum)
· LMS (Swedish BMA) degree, BSc or MSc, Cell Biology, Microbiology or related field
Quality Control Associate, full time position.
Welcome with your application no later than November 8, 2019. We apply continuous evaluation of applicants, therefore this position can be filled before due date.
For more information, please contact firstname.lastname@example.org
Phone +46 765 250 904