English
The company’s missions:
• Using the IMMray™ platform to develop and establish more precise and reliable tools for the early detection of complex conditions such as cancer.
• Establishing the IMMray™ based blood test for early detection in pancreatic cancer high-risk groups.
Immunovia’s strategy is to decipher the wealth of information available in blood – and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible. Immunovia’s unique technology platform – IMMray™ – is an antibody-based multiplex test that is designed to provide a snapshot of the immune system response – based on the information available in a single drop of blood. But IMMray™ is more than a technology, it is a systematic approach, based on cutting-edge bioinformatics, to finding the most clinically relevant changes that appear in the blood, and combining this knowledge into a “disease fingerprint” – also called a biomarker signature – that is highly specific to the particular disease.
In 2017, Immunovia, Inc. was established in Marlborough, Massachusetts. The IMMray™ PanCan-d test, the first blood-based test dedicated to the early detection of pancreatic cancer, is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see www.immunoviainc.com. In addition to the USA, Immunovia aims to launch the test in suitable markets in Europe and Asia with the aim of providing global access to the test.
In collaboration with Create HEALTH Translation Cancer Center at Lund University and others, Immunovia also has ongoing projects in the discovery phase targeting other cancers.
Immunovia has developed since 2016 a clinical prospective study program in the three main risk groups for pancreatic cancer as follows: PanFAM- 1 is the clinical study for individuals with familial/hereditary pancreatic cancer, PanSYM-1 for patients with early non-specific symptoms suggestive of pancreatic cancer and PanDIA-1 designed for individuals at risk due to the diagnosis of new onset diabetes after the age of 50. These three large clinical studies cover today more than 10 000 subjects recruited at 30 sites in the US and Europe.
Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden.
Immunovia has been a listed company since 2015, with shares traded (as IMMNOV) on Nasdaq First North in Stockholm and since April 2018 traded on Nasdaq Stockholm.
The headquarter is based at Medicon Village in Lund, Sweden and has today 60+ employees, 44 in Lund and 24 in US.
For more information, please visit www.immunovia.com
TILLSATT - QA Specialist
Company: Immunovia AB
Role: QA Specialist
Reporting to: QA/RA Director
Place of position: Lund, Sweden
The role as QA Specialist
General description and main responsibility
As a Quality Assurance Specialist at Immunovia AB, you will play an important role in the work related to Immunovia’s Quality Management System (QMS), high emphasis will be put on QMS development, maintenance and overall documentation for the products during design and development, and continuous life cycle. You have the capacity to translate QA requirements into procedures in a dynamic and relevant QMS system.
The QA Specialist will support in the implementation of the QMS within the organisation of Immunovia. Experience from software specific processes in the Quality Management System is an advantage. It is important that you have a can-do attitude and the ability to creatively solve problems.
We are looking for a strong communicator, with the ability to work across teams with different people in a pragmatic way. Good time management and meeting deadlines to drive performance is important in this position.
The position will report to the QA/RA Director.
Tasks and responsibilities include, but are not limited to
• Develop, implement and monitor companywide quality system based on IVDR 2017/746, US FDA regulations and international standards such as ISO 13485 and ISO 14971
• Administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
• Active participate in all stages of Design Control and Risk management processes for the products
• Provide support for release of products
• Release of products
• Participate in all stages of product, process, method and instrument validation/qualification and validation of IT processes
• Coordinate and maintain the Validation Master Plan
• Review and approve technical documentation and quality specifications
• Participate and lead all stages of Nonconformance, Change Control and Corrective and Preventive Action (CAPA) procedures
• Active participate in the preparation of regulatory documents and reports
• Act as a company liaison during customer and regulatory quality and qualification audits and inspections. Ensure any corrective and preventive actions during external audits are communicated and implemented in a timely manner.
Requested qualifications
• MSc in natural sciences like biology, biochemistry or chemistry
• Substantial experience from QA and experience from working with Software, within the IVD/Medical Device industry
• Strong communication and presentation skills in both written and oral forms
• IT skills, proficient with Microsoft Office products
• Fluent in English and Swedish
Personal characteristics
• Driving personality with ability to prioritize tasks to accomplish goals and objectives, initiates and generates activity
• Excellent communication, presentation, and intercultural skills
• Ability to work in a team and share responsibilities and tasks
• Ability to analyze data, interpret results and translate outcome to action
• Analytical with ability to tackle problems and take actions, act on opportunities, and generate new ideas
• Capacity to translate QA requirements into procedures in a dynamic and relevant QMS system
• Adapts to changing circumstances and works productively in a high-pressure environment
Opportunities with the role
You will be part of a dedicated team working towards Immunovia’s vision to lead the development of bioinformatics assisted diagnosis so that all patients are diagnosed in time for effective treatment, something which in turn results in a better quality of life and significantly higher survival rates.
You will join a growing organization that puts people in focus, with an engaged management team in a company with short decision-making processes. There is an informal and personal atmosphere where each employee's contribution is important for the company's development and results. Be part of a company characterized by a fantastic team feeling and where they have mandatory “fika med knäckebröd” every day.
Immunovia is taking the next important step in bringing a solution to the unmet need of early detection of pancreas cancer to the market, by development of a world leading technology from Lund university to a clinical laboratory testing for early diagnosis of pancreatic cancer.
Contact
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Sr Recruitment Consultants at PeakSearch.
catharina.herbertsson@peaksearch.se, +46 (0)706 152 772
eva.runnerstrom@peaksearch.se, +46 (0)701 725 379
www.peaksearch.se
Application
Apply for the position at www.peaksearch.se