Quality Engineer to BioLamina

Quality Engineer to BioLamina
Are you meticulous in your work and take pride in addressing all the details in what you work on? Are you at the start of your career and interested in working with Quality? Then you might be the candidate that BioLamina is looking for!
We will have an ongoing selection process so please send in your application as soon as possible.
About the Position
You will support our Quality Assurance team. The Quality Department at BioLamina is responsible for establishing in-house quality procedures, standards, specifications, systems, and to support other departments to ensure that the operations at BioLamina meet outlined requirements. Since BioLamina is an entrepreneurial company, there will be great opportunities for you to help shape, structure and implement Quality routines, as your thought and ideas will be highly valuable in your role. You will strengthen our Quality team with this new role that will assist our quality assurance staff with quality documents life cycle handling. You will work cross-functional with highly experienced Quality Mangers, enabling you to grow and evolve in your role, with the ability to have a career within the Quality field.
The position is full time and located in Sundbyberg, a close suburb to Stockholm (ca 6 km from Stockholm city), with excellent commuting opportunities (bus, tram, subway and train).
Responsibilities
The roles responsibilities include but is not limited to:
• Review and updating of specifications for starting materials and consumables
• Review and document assessments of supplier notifications
• Harmonizing current quality standards and implementing new standards
• Improve the quality system by making recommendations for change
Your Profile
• You have a Master´s or Bachelor’s degree within the Life Sciences area, e.g. apothecary, chemistry, drug development or pharmaceutics in an accredited higher education institution.
• You must fulfill the formal educational requirements for Qualified Person (QP) according to HSLF-FS 2021:102 §13 (previously LVFS 2004:7), with a minimum of five weeks per course.
• The role requires you to work independently with short- and long-term deliveries, in collaboration with our QA managers. Courses, knowledge or hands on experience that is advantageous to have for this role are within GMP regulatory standards and framework, manufacturing quality systems, biotech and/or ISO9001:2015.
• You have working knowledge of statistics
• You have excellent English language skills (equivalent to CEFR C1 level or higher), both spoken and written.
About the Organisation
BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We are a growing team around 60 people working within manufacturing, R&D, Quality and Customer service. BioLamina has over 27 nationalities represented in the company which creates a highly dynamic and inclusive culture. Our corporate language is English.
BioLamina produces and develops premium laminins, which are proteins used in e.g. stem-cell research. Our quality system is developing, and so the entire company, and we’re striving to launch a product line in according to GMP within a few years. The company has a certified Quality Management System according to ISO 9001:2015.