Quality Control Associate to Takara Bio Europe AB
HR On Demand / Biologjobb / Göteborg
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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 (
http://www.takarabio.com/)The company is now looking for the following competence for a limited period of time.
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 ensures that work is consistent with the overall strategic direction of the Quality department and Takara Bio Europe AB. This is accomplished through close collaboration with team members and the organization.
Primary Duties & Responsibilities
• Follow Quality Management System processes and procedures (i.e., document review and management, validation, change control, deviations, corrective action/preventative action, training, quality control, material receipt, OOS/OOT and specifications etc.).
• Develop Quality System processes, i.e. writing and reviewing SOPs within the QC area and other related documents within the Company Quality Management System.
• Responsible for environmental control of clean room areas in the facility.
• Take part in general maintenance activities in the clean room area.
• Issue, review and assess QC batch related documentation and environmental control documentation.
• Issue deviations related to Quality control to identify root cause and corrective and preventive actions.
• Issue Change documentation related to the Quality control function.
• 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
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.
• Normally receives no instructions for routine work, general instructions on new assignments
• Work during weekends may be a temporary requirement.
• Other required duties may be assigned.
Education Requirement (minimum)
• BSc or MSc, Cell Biology, Microbiology or related field
Welcome with your application no later than May 31, 2019.We apply continuous evaluation of applicants, therefore this position can be filled before due date.
For more information, please contact
Dan_Lundin@takarabio.com.
Phone +46765250 960
Varaktighet, arbetstid
Heltid 2019-12-31, with the possibility of extension
Publiceringsdatum2019-05-08ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-05-31
Klicka på denna länk för att göra din ansökanKontaktDan Lundin, Takara
FöretagHR On Demand
AdressHR On Demand
Lilla Bommen 1
41104 Göteborg
KontorsadressLilla Bommen 1, Göteborg
Jobbnummer 4780138
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