Quality Assurance Associate
Il y a 7 mois
**QA Associate**
As a global Research Organization to the biopharmaceutical industry, **CellCarta (formerly Caprion - HistoGeneX)** provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.
We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.
CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.
We are currently recruiting**:QA Associate**
Department**:Quality Assurance**
**Based in**
Wirlijk, Antwerp (Belgium)
**Purpose of the function**
The Quality Assurance Associate works as member of the Quality Assurance team of HGX, ensuring that all activities are performed in accordance with GCP, GCLP, CAP/CLIA, ISO 15189 and ISO 13485 standards.
**Major responsibilities**
The QA associate contributes to the following in the QA team:
- Coordinate and plan QA related onboarding training for new employees
- Administer the electronic Quality Management Systems
- Manage the users and reading task in the electronic Quality Management System (Document administration role)
- Manage the training courses in the eQMS (Training coordinator role)
- Word processing support for procedures and related documents
- Work as needed with the (senior) QA managers to develop training materials
- Preparation of vendor questionnaires and other support in the supplier control process
- Assist in the Proficiency Testing program
- Assist in sponsor and regulatory inspections (preparation and follow-up)
- Assist in administrative tasks and collaborate with colleagues to ensure that everything is running smoothly
- Perform routine QA assignments using existing procedures
**Qualifications and skills**
- Bachelors’ degree preferred or equivalent by experience
- Attention to detail
- Good Communication skills (verbal and written)
- Ability to work as part of a team
- Multitasking and time management
**Reporting**
The QA associate reports to the Site Head QA, or a (Senior) QA manager.
**What can we offer**
- A dynamic and rapidly changing global environment allowing personal growth
- A company that is fit for the future
- A competitive salary and benefits
- A great team you can work with
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