Quality Control Associate

Quality Control Associate to Takara Bio Europe AB
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 and culture media. For more information, visit our website: www.takarabio.com.
Takara Bio Europe AB is now looking for a person joining our expanding Quality team. As a part of our team, you will be working with environmental control in the clean rooms as well as with bioanalytical methods (such as SDS-PAGE, PCR, Flow Cytometry, Immunostaining) and cell culture-based assays in the wet lab. We are working with research grade as well as GMP (Good Manufacturing Practice) grade products which requires knowledge and adherence to Quality principles and standards including GMP and pharmacopoeia. Our new team member will after appropriate training work independently, executing the tasks in alignment with our QMS (Quality Management System).
Scheduled work performed during weekends may from time to time be a requirement as we are working with living cells. This position reports to the QA/QC Manager.


General Duties & Responsibilities
Performs routine work independently and adds new tasks after training
Relies on instructions and pre-established guidelines when executing tasks.
Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.
Maintains knowledge of Quality Control processes and standards.

· Other required duties may be assigned.

Primary Duties & Responsibilities
· Perform environmental control of clean room areas in the facility.
· Perform quality control assays, including cell culture-based methods of stem cell products.
· Issue, review and assess QC batch related documentation and environmental control documentation
· Write and revise SOPs in order to maintain and develop the Quality Control processes and procedures.
· Take part in Deviations, Change Controls and risk assessments related to quality control.
· Participate in qualification and validation activities of QC equipment, systems and processes
· Act as contact person for external suppliers for QC service.
· Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
· Provide support with audit/inspection requirements to ensure department compliance/readiness.
· Take part in general maintenance activities in the clean room area.
· Assess and Trend environmental control results.

Education/ Experience Requirement
· BSc or MSc in Pharmacy, Cell Biology, Microbiology or related field
· >3 years relevant experience preferably in the biotech, biologics, medtech, and/or pharmaceutical area
· Hands-on experience of work in the wet lab as well as with cell culture is an advantage
· Experience of work in clean room area within GMP is an advantage
· Experience of work with ATMP products is an advantage
· Knowledge about applicable Quality guidelines is an advantage
· Flexible and agile, capable of handling multiple tasks and changing priorities
· Good command of the English language in speaking and writing

We are looking for you who can act in a rapidly developing field, are flexible and are enjoying having a variety of different tasks. We can offer you a familiar and dynamic environment where each person in the team makes a difference.


Position
Quality Control Associate, full time, 12 months contract, with the possibility it will become a permanent position.
Welcome with your application no later than November 22, 2021. We apply continuous evaluation of applicants; therefore, this position can be filled before due date.
For more information, please contact karin_noaksson@takarabio.com
Phone +46 765 25 09 72