QA/QC Associate Molecular Biology

QA/QC at Takara Bio Europe Swedish Filial
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group added IVD (in vitro diagnostic) kits using PCR technology to its portfolio.
To strengthen our ability to support our customer needs in the European market, TBESF will expand its operations into molecular biology tools and we are now looking for a QA/QC associate to join our team. You will work closely together with our project manager to prepare our facility and management system for the implementation of molecular biology tools production at the site. The long-term goal is an ISO13485-certified manufacturing site with QC capabilities to support our European customers. In the near future we will contribute with ISO 9001 molecular biology tool products assembled according to customer needs.
We are looking for a person with quality focus experienced in the MDR and/or IVDR area. Preferably you have been working with both implementation projects for manufacturing as well as quality assurance and quality control including environmental monitoring, within medtech. You feel confident in your quality role and understand the importance of being pragmatic but within the boundaries. You will be part of the quality team and report to the Associate Director Quality


Work description
Project phase:
· Drive the quality agenda during the implementation of molecular biology tools at the site
· Update our current QMS with adaptions to support our molecular diagnostics business (initially ISO9001, long term 13485)
· Implementation of QC equipment and methods (PCR) to support the production
· Implementation of environmental and personal monitoring (EM/PM) for the clean rooms
Operations phase:
· Manage QMS
· Perform EM/PM for clean rooms
· Perform QC tests (including PCR) on manufactured products
· Manage change controls and deviations and other processes supporting the production and monitoring trends
· Release of raw materials
· Manage, evaluate and qualify suppliers
· Host/support audits

Matching candidate:
· Masters Degree in relevant area
· Work experience within quality for medical device and/or IVD (ISO13485/MDR/IVDR)
· Hands on experience of working with PCR and/or EM/PM
· Participated in QMS implementation and/or update and/or administration
· Experience of supplier management
· Strong quality agenda
· Auditor and experience of hosting audits


You will be an important part of our new offer within molecular biology during the implementation and in later operation. There will be a variety of tasks including hands on tasks in the lab and clean room and the ability to work independently is required. We can offer you a familiar environment where each person is doing a difference.
Welcome with your application no later than March 31, 2023. We will start the evaluation of candidates as they arrive, and the position can be filled before due date.

For more information please contact anna_gunnerling@takarabio.com
phone +46 765 25 09 61