QA/RA 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

Randstad

At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential.

With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world’s most valued working life partner. By combining our passion for people with the power of today’s technology, we support people and organizations in realizing their true potential. We call it Human Forward.