Quality Assurance Scientist

About ANGLE:

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE’s proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix® system.   ANGLE’s Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.

The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells to the user in a format suitable for multiple types of downstream analyses.  The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility.  The system is epitope independent and can capture all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive).  CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient’s tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient.

Join our Team:

The Quality Assurance Scientist will join ANGLE’s Product and Technology Development (PTD) department and will work within a skilled interdisciplinary team consisting of Scientists and Engineers.  You will provide day-to-day support to the PTD team on quality management subjects, carry out laboratory-based activities and work with ANGLE’s Quality and Lab Management teams to ensure compliance with our Quality Management System.  Goals and routes will normally be agreed daily with your supervisor, but an ability to work independently is expected.

At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading edge translational research into clinical diagnostics. We offer the potential for significant corporate growth and career development. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.

We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please describe your background and what you can bring to our team along with attaching your resume.

Principal Accountabilities:

  • Hands-on laboratory work, primarily in medical device development
  • Provide quality assurance focussed scientific, engineering and technical support to PTD and Manufacturing staff, programmes and projects
  • Support PTD team compliance with the Quality Management System
  • Developing and updating ANGLE PTD procedures in line with operational and Quality Management System requirements
  • Undertake actions related to addressing issues raised in open CAPAs, defect reports, and customer/stakeholder complaints
  • Lead and assist with the completion of quality records and perform appropriate investigations, impact and risk assessments
  • Responsible for accuracy, quality and regulatory compliance of work undertaken
  • When required, train staff to reinforce best practice
  • Independently keep a current knowledge base in relevant areas of scientific, engineering and technical research
  • Support the day to day running of development projects in the PTD team within the Quality Management System (ISO13485:2016) and working to the New Product Development (NPD) operating procedure
  • Participate in the hand-over of newly developed products to the Verification and Validation team as part of the product development process
  • Support quality audits as required
  • Undertake additional adhoc tasks as required

Qualifications, Experience, Knowledge and Attributes:

  • B.Sc. or equivalent in Life Sciences or Engineering
  • Post-graduate laboratory experience gained in the in vitro diagnostics industry
  • Experience working to strict quality standards such as Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, IVD 98/79 EC, ISO14971, GMP, GLP, QSR. A strong understanding of the importance of a strictly controlled quality system is essential
  • Experience of using a CRM system such as Zoho is highly desirable
  • Proficient in Microsoft Office Suite
  • Familiarity working with a New Product Development process
  • Good knowledge of biostatistics
  • Strong organisational skills and the ability to rapidly prioritise tasks in response to unexpected opportunities or risks
  • An eye for detail and commitment to high quality data
  • A flexible, can-do approach to the requirements of the job

Due to the nature of the role, our requirement is for this position to be Guildford based, office hours, five days per week.

As a member of our highly skilled and fast-growing team you will receive opportunities for development and a competitive benefits package.

Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.

Furthermore, please be advised that if you submit an application to us for this position, your application and personal details will be processed in accordance with our Data Privacy Notice for Job Candidates.

Important notice to Employment Businesses/ Agencies:

ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any candidates. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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