Quality Specialist II, Ops Quality & Systems

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary

Do you want to be part of our journey into the future? We produce products which are used in break-through technologies, lifesaving assays and clinical applications that demands high attention to quality assurance in all steps of the production and control processes. Our customers are world leading pharma and diagnostics companies which have chosen us as their business partner. This means that we as a company must continue to develop and improve our quality systems on an outstanding level.

We are now looking for a new colleague to join our dedicated Quality Assurance team in Norway. It is a highly motivated and diverse team of 15 colleagues with a passion to ensure high quality of products/services to our customers. Please not that this is a fixed term position for one year.

Responsibilities:

• Collaborate across function, leveraging others’ quality and manufacturing expertise to troubleshoot problems, interpret data, determine next steps, and create technical report
• Maintain controlled documents through the electronic Documentation Management System
• Release product according to the requirements of the QMS
• Provide Manufacturing and QC support, including QA approval of changes and document change orders
• Undertake Environmental Monitoring Activities
• Ensure compliance with site procedures, regulatory requirements and industry standards in line with ISO1348
• Perform compliance evaluations to ensure alignment with internal procedures, regulatory requirements, and industry standards

Requirements:

• Bachelor’s degree or Master’s degree in biology, chemistry, biochemistry, chemical engineering, Information Science or a related field
• Experience working in a QA function within Life Sciences, Chemistry, Food Industry or Pharma sectors preferred
• Candidates with a QC or manufacturing background within these sectors will also be considered
• Experience within product release or process development would be a benefit
• Experience working under ISO 13485 or ISO 9001 in a related industry
• Experience from positions in QC or Manufacturing is an advantage
• Experience from positions in QA is an advantage, but not required 
• Fluency in a Scandinavian language and English
• Excellent interpersonal and communication skills
• GMP experience is advantageous

Personal Attributes Sought
You are solution oriented, analytical, resourceful, accountable and with close attention to detail. You have a strong desire for continuous improvement. You are structured, data-driven, and able to communicate clearly across functions. You have the ability to quickly learn and adapt to new systems and software. You create an environment where individuals feel valued and motivated. You are self-driven and act independently. 

What We Offer

• Good development opportunity, working within a large dept. of highly skilled colleagues
• Great working relationships with other parts of the business  
• Becoming part of a global organisation with possible onward opportunities
• Insurance and annual bonus