Quality Assurance/Regulatory affairs Associate

Job description
Are you a QA or RA professional looking for a new challenge? Do you have experience working in the medical device industry? Does working within a small, expert team appeal to you?
If the answer to these questions is YES, the position at CytaCoat could be the next exciting step in your career.
In the position as QA/RA associate you will be responsible for supporting management and development of the Quality Management System (QMS) and regulatory obligations of the organisation and its products throughout the full product life cycle. The QA/RA associate works to ensure that products and procedures adhere to CytaCoat´s quality standards and regulations. You will also be conducting assessments, review documentation, coordinate with staff and managers and develop comprehensive reports.
This position will report to the Program and QA/RA Manager and will be based in Solna, on the old Karolinska Hospital site in spacious, dedicated laboratory facilities.

Responsibilities
Review lab data, validation and stability protocols/documents, batch records, specifications for compliance.
Support manufacturing through timely process of deviations, change controls, CAPA complaint handling, and investigations to ensure quality products.
Author and update SOPs as needed.
Follow guidelines and adhere to SOPs and regulatory requirements.
Communicate QA issues to employees and managers.
Review quality management system periodically to assess suitability and areas of possible improvement.
Carry out QA inspection functions as assigned by the management.
Develop and maintain procedures and process documentation.
Assist R&D and Production in equipment and method validations.
Assist in the drafting, review, management and control of clinical trial documentation.
Work on multiple projects simultaneously with changing deadlines and priorities.


Qualifications
BSc in Chemistry, Microbiology or related science.
1+ years of experience working in a similar position.
Experience working in a laboratory or process manufacturing setting according to GMP.
Fluency in written and spoken Swedish and English. We are an international team and English is our primary language.
Experience in technical writing and competent in accurate document review.

We are looking for someone who:
 
Is detail oriented
Works well under pressure
Has the ability to prioritize
Has strong verbal and written communication skills.
Desires to work in an office setting as this position is not laboratory focused.
Has great social skills.


About the company

Cytacoat AB
CytaCoat AB is a private Swedish company located at the Karolinska Hospital site in Solna (Stockholm area). The company was founded by a group of researchers from the Karolinska Institute and the Royal Institute of Technology (KTH). The goal was to develop a new technology for coating medical devices based on a discovery that CytaCoat´s proprietary polymer surface coating technology exhibits a clear effect on several of the most problematic bacteria that pose problems in healthcare today. Since then, the company has been focused on transforming this innovation into fully viable commercial products. We identify a need in the market and develop a coating to fit a particular device. To do this, we form manufacturing and development partnerships to first develop, produce, and test a coated device then undertake clinical trials to provide evidence for the effectiveness of the coated product.

CytaCoat has fully equipped laboratories where chemistry, microbiology evaluation, research and development, and pilot plant production is undertaken.

We are building the capabilities to produce finished packed sterile product via collaboration with our manufacturing partners and this product will be made available as Original Equipment Manufacturer (OEM) product to medical device companies and also to distributors. Additionally, our technology will be brought to market via licensing to medical device companies for them to coat their products and take them to market.