Quality Assurance/Quality Control Associate

Company
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.


General Duties & Responsibilities
· Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.
· Maintains knowledge of Quality Control processes and standards.
· Exhibit general knowledge of professional ethics, laws and regulations.
· Relies on instructions and pre-established guidelines to perform the job.
· Normally receives no instructions for routine work, general instructions on new assignments.
· Scheduled work performed during weekends may from time to time be a requirement.
· Other required duties may be assigned.
· Reports to Quality Manager.


Primary Duties & Responsibilities
· Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
· Review and assess manufacturing batch documentation and QC documentation.
· Review, approval and closure of deviations and non-conformances ensuring adequacy of investigations, root cause and appropriate CAPAs.
· Review, approval and closure of Change documentation ensuring relevant Quality requirements are met.
· As needed take part in or act as facilitator for Quality related Risk Assessments.
· Take part in audits and regulatory inspections.
· Maintenance and Development of Quality processes and procedures.
· Perform environmental control of clean room areas in the facility.
· Perform quality control assays of stem cell products.
· Take part in general maintenance activities in the clean room area.
· Issue Change documentation and Deviation documentation related to the Quality Control function.
· Issue qualification and validation documentation for QC equipment, systems and processes.
· Issue, review and assess QC batch related documentation and environmental control documentation.
· Assess and Trend environmental control results.


Education/ Experience Requirement
· MSc in Pharmacy, Cell Biology, Microbiology or related field
· >3 years relevant experience preferably in the biotech/biologics area
· Experience of work with ATMP and/or stem cells is an advantage
· Experience of work in clean room area within GMP is an advantage


We are looking for you who can act in a rapidly developing field, are flexible and are enjoying having a variety of different tasks.


Position
Quality Assurance/Quality Control Associate, full time position.


Welcome with your application no later than December 18, 2020. We apply continuous evaluation of applicants; therefore, this position can be filled before due date. #jobbjustnu


For more information, please contact karin_noaksson@takarabio.com
Phone +46 765 250 972