We believe there is a smarter, more data-driven way to make decisions in health. As we pass 1,000,000 genomic profiles analyzed and look to the future of our platform, we are now searching for a Quality Associate who will be be part of a dynamic and exciting international team. Our SaaS DATA Platform combines deep expertise in life sciences and medical disciplines with mathematical capabilities in data computing.
Our mission is to bring data analytics solutions to market, to support healthcare professionals by maximizing the power of Data-Driven Medicine. SOPHiA GENETICS (NASDAQ: SOPH) combines collective intelligence in Genomics, Radiomics, clinical research data, the DDM - Data-Driven Medicine, we can ensure that the data used to help patients today will also benefit the patients of tomorrow.
Be part of our mission to disrupt the traditional healthcare model and democratize data driven medicine! SOPHiA GENETICS is looking for a talented QA Specialist to join the Quality Assurance and Regulatory Affairs (QAamp;RA) teams at our headquarters in Rolle, Switzerland.
Globally, this person will ensures that the quality processes are well applied in the company and up to date with the regulation requirements.
Main responsabilities :
- Assure the Technical Release of the semi-finished and finished product in compliance to regulations, regulatory dossiers and product specifications.
- Review batch records (production and packaging) and generate related quality certificates.
- Release product (incoming, semi-finished and finished product)
- Following deviations related to laboratory and manufacturing (production, supply chain and laboratory) with the concerned functions.
- Following complaints investigations.
- Creation and Review GMP documents related to production area (SOP's, specifications protocols, reports..), preventive maintenance plan and SOPs and validation/qualification documentation related to production area.
- Coordinate technical equipment maintenance activities with external contractors.
- Establish compilations and trending of GMP data.
- Participate in audits in self-inspections and external audits.
- Evaluate any signal detection of potential product quality impact and participate to resolve significant quality issues.
- Assure a communication flow and collaboration with operations and other functions to assure a product life-cycle quality
- Follow up on Quality findings detected during internal / external / customer audit’s
- Assist during external amp; internal audits
Requirements
- Bachelor / Master in a Scientific field (preferably: Biology, Biotech, Bioinformatics)
- 3-5 years of experience in Quality Assurance
- Working knowledge of ISO 13485 and ISO 14971, FDA QSR, the GxP standards with previous experience in a quality role within the Medical Devices or Pharmaceutical Industry.
- Demonstrated ability to manage and optimize an ISO 13485 compliant Quality Management System.
- Strong knowledge of Pack Office (Excel, Word, PowerPoint)
- Fluent in English is a must. Any other language is a nice-to-have.
Benefits
You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth.
Business recognition and accolades include:
- World's most innovative companies (Top 10)
- World's smartest companies (Top 50)
- 100 Best Places to Work in Boston
- Top 10 European Tech Startup - 2020
- Top 10 European biotechs startup to watch - 2021
- Top 25 East-Coast Biotech to watch - 2021
Plus, you will find :
- A flexible, friendly, and international working environment with a collaborative atmosphere
- Flexible working hours, including hybrid remote / on-site working model
- An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
- A fast-growing company with plenty of opportunity for personal growth and development
- A hard technical challenge to solve with exciting modern technology - cloud computing, Big Data, DevOps, machine learning
Location: Rolle, Switzerland. Office-based
Start: ASAP (or as agreed)
Contract type: Permanent, full-time
Application process
If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.
After an initial screening process, candidates will be invited for remote interviews.