QC Scientist with flair for QA – the link to customer satisfaction
Do you want to take up the professional challenge of honoring customer demands? Do you have a real passion for quality, and do you enjoy providing scientific guidance and support to external as well as internal stakeholders linking validations and QC test demands?
Our customers are world leading pharma and diagnostics companies who have chosen us as their business partner, and we take great pride in being there for our customers, ensuring total customer satisfaction. At the Roskilde site we produce a variety of consumables (branded NUNC) for the medico and biotech industry. Our vision is to make the world healthier, cleaner & safer.
Due to growth, and the establishment of our new irradiation business line we are now looking to recruit a dedicated QC Scientist to support our commitment to our customers – ensuring we uphold the highest standards.
Working as part of the QC-laboratory team, you will be the project lead from a quality perspective in collaboration with our Customer Service Specialist. The position will involve development and setting up tailored customer specific processes and tests.
- Controlling and managing the irradiation sterilization processes of medical devices. Optimizing documentation, dose mapping verification, calibration of measuring equipment to comply with regulatory requirements and standards (ISO 11137 and ISO 11737)
- In relation to irradiation customers; supporting development of tailored customer specific QC tests to meet requirements according to standards and USP-methods, and completing certificates of analysis
- Involved in implementation and validation of software, in addition to planning and initiating of product shelf-life projects under GMP
- Defining protocols and validating new tests in cooperation with R&D, QA, the Production and Product Management (ISO 13485)
- Trouble shooting as part of complaint handling and non-conformances (CAPAs)
The right candidate will thrive in a hectic environment; have real integrity with a can-do attitude and great passion for quality. You will take great pride in your personal deliverables and enjoy customer facing contact.
Experience and qualifications needed to succeed
- Cand. Scient. or candidate degree in biochemistry, biomedicine & technology, pharmacy or equivalent
- Demonstrable competence and experience in developing and working with protocols and validation of software and processes under GMP and GDP
- Working experience with ISO 11137, ISO 11737 & ISO 13485
- Experience with setup and implementation of sterility tests, immunologic analysis and microbiologic tests
- Motivated by improving and optimizing processes using LEAN tools
- Knowledge of irradiation for sterilization and plastic surfaces is an advantage
- Ability to work independently, analytically and structured, and capable of translating and communicating complex information
- Committed and self-driven with a positive mindset, flexibility and persistence
- Good strong communication skills in Danish and English adept with communication at all levels as well as with customers /stakeholders in a professional and effective manner
What we offer
- A career in an international company with global impact
- Be part of exciting project to improve human condition
- Development through continuous learning
- Cooperation with driven colleagues across business areas
- Opportunity to work with the best teams in the industry, ranging from international top level scientist to cutting edge process- and production teams and highly creative business- and marketing teams
Application deadline is June 23rd 2017 - with first round of interviews planned for week 26
If you have questions about Thermo Fisher and/or the position please contact Bodil Søndergaard (QC Laboratory Team leader) via email email@example.com
We look forward to receiving your application including a motivational letter and a CV