QA/QC Associate

Quality Assurance and Quality Control Associate to Takara Bio Europe
About the company: Takara Bio Europe, formerly Cellartis, 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 has a newly established GMP laboratory for production of pluripotent stem cell lines and related media. For more information, visit our website: www.takarabio.com


About the position: The Takara Bio Europe is now looking for a person joining our Quality team. As a part of our team, you will be working hands on with environmental control in the clean rooms, with bioanalytical methods (such as Flow Cytometry, SDS-PAGE, PCR, Immunostaining) and cell culture-based assays in the wet lab as well as more administrative tasks related to the QMS (Quality management system).
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 methods. Our new team member will after appropriate training work independently, executing the tasks in alignment with our QMS.

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), ISO 9001:2015 and pharmacopoeia standards for QC methods
Maintains knowledge of Quality processes and standards.
Cooperation with production and supply chain teams


Primary Duties & Responsibilities
Perform environmental control of clean room areas in the facility.
Perform quality control assays, including cell culture-based assays of stem cell products and media
Issue, review and assess batch related documentation and environmental control documentation
Work with Deviations, Change Controls and risk assessments
Manage and implement QMS documentation during review and approval process
Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
Maintenance and development of Quality processes and procedures
Support in customer audits and authority inspection
Take part in general maintenance activities in the clean room area.
Review qualification and validation documentation of equipment, systems and processes
Perform internal audit
Assess and Trend environmental control results.


Relevant education and experience
BSc or MSc in Cell Biology, Molecular Biology, Microbiology, Pharmacy, or related field
>3 years relevant experience preferably in the biotech, biologics and/or pharmaceutical area
Hands-on experience of work in the wet lab as well as cell culture
Experience of work in QA department (QMS, deviations, audits etc) in regulated area (GMP and/or ISO 9001)
Experience of work in clean room area within GMP is an advantage
Experience of work with ATMP products is an advantage
Knowledge about applicable guidelines is an advantage
Flexible and capable of handling multiple projects and changing priorities
Good command of the English language in speaking and writing


We are looking for you who are enjoying having a variety of tasks performed in a quality regulated environment. You will be working independently, being an important part of our company to offer stem cell products to the market. We can offer you a familiar environment where each person is doing a difference.


Postion: QA/QC Associate, full time, temporary position 11 months, reporting to QA/QC Manager. Scheduled work performed during weekends may from time to time be a requirement.
Welcome with your application no later than November 22, 2022. We will start the evaluation of candidates as they arrive, and the position can be filled before due date.
For more information and application, please contact anna_gunnerling@takarabio.com
phone +46 765 25 09 61