ArcticZymes Technologies are now looking for a talent to join their QA and Regulatory Department!

QA Associate

Born from the unique conditions of the Arctic - ArcticZymes Technologies is a biotechnology company selling cold-adapted enzymes and enzyme solutions to industrial customers in a global market. Through collaboration and partnership, the company has more than 30 years of experience in developing unique and high-quality enzymes - enabling new solutions and technology development within molecular biology research, diagnostics and biopharmaceutical manufacturing.

The company is growing fast and currently has about 60 employees located in Europe, USA and Asia with main office, R&D and production, in Tromsø. Our growing product portfolio and increased requirements for quality assurance, means that ArcticZymes Technologies are expanding, and we are looking for a highly motivated QA Associate to join us to help accelerate our growing business in our QA and Regulatory Department.

QA Associate

As a QA Associate for ArcticZymes Technologies, you will be responsible for supporting the implementation and operation of ArcticZymes Technologies Quality Management System. The role aims to ensure the site remains in a state of GMP compliance providing expert advice relating to GMP and by actively participating in investigations, audits, data reviews, validation projects, and the delivery of GMP related training.

Tasks and responsibilities

• Reviews and approves quality documents (Policies, SOP's, batch records, protocols, reports) to ensure compliance with GMP, AZTs document management procedures and other applicable quality standards.
• Supports the supplier qualification program by participating in assessments and leading third party audits
• Assists in support of the internal audit program by scheduling and conducting internal audits.
• Participates in projects to ensure facilities, utilities, equipment, and computer systems are appropriately validated/ qualified, approval of key validation deliverables
• Batch review and release/ rejection of incoming raw materials
• Supports the QMS, helping to ensure the site-specific requirements are addressed.
• Reviews and approves quality events, including deviations, OOS investigations, change controls, and CAPA
• Performs other duties as assigned

Qualifications

• BSc/Master's degree in biotechnology, biology, biochemistry, chemistry, pharmacy or similar
• Minimum of 2-5 years of experience in the pharmaceutical or biomanufacturing industry
• In depth knowledge of Good Manufacturing Practice Regulations
• Experience of industry quality systems/standards, e.g. ICHQ10, ISO 13485, ISO 9001
• Experience, knowledge, and hands-on experiences of pharmaceutical manufacturing processes
• Experience in submission of DMF (preferable)
• Strong communication skills with the ability to interact with all levels throughout the organization
• Fluent in both written and spoken English

Location/Reporting

• Preferably Office based in Tromsø or Oslo, alternatively remote.
• 20-25% travel should be expected if the candidate is not based in Tromsø
• The candidate will report to QA and Regulatory Manager

We offer

This is a unique opportunity to join one of Norway's fastest growing biotechnology companies to develop new technology and products advancing life science research, diagnostics & bioprocessing. We offer an independent role in a space characterized by professional and personal growth. Flexible working hours, competitive salary and insurance.

We evaluate CV's and applications continuously, and if you have questions regarding the position please do not hesitate to contact Consultant Ingvild Ringen tlf: (+47) 988 04 308 or Branch Manager Thomas Lund tlf: (+47) 401 08 070.

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As an Equal Opportunities employer, we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.