Quality Assurance (QA) Specialist
About us
BioClavis Ltd is a Glasgow-based spin-out of USA-based BioSpyder Technologies, Inc. BioSpyder™ has developed a novel product for targeted sequencing called TempO-Seq™, a gene expression profiling tool designed to monitor hundreds to thousands of genes at once in high-throughput. TempO-Seq™ can analyse expression in samples with thousands of cells or from single cells without pre-amplification, maximising utilisation of precious or limited samples. BioClavis utilises the TempO-Seq™ assay to deliver an easy-to-use solution for customers doing expression profiling for any species.
We’re ambitious, growing rapidly, and seeking talented and motivated individuals to join the team.
How you’ll spend your day
In our dynamic environment, there is no typical day. You will work closely with, and report to, the Technical Operations and Quality Assurance Specialist, ensuring that all laboratory processes are carried out to the standards required for ISO 15189 accreditation for both BioClavis and BioSpyder Technologies. You will be responsible for developing and managing the Quality Management System (QMS), ensuring procedures are in place for operational governance and compliance.
roles and responsibilities
Perform quality assurance checks to ensure efficiency and accuracy, maintaining quality assurance records and documents.
Control and manage the evaluation of suppliers and validation of reagents.
Ensure the validation of equipment and other instruments required to process clinical samples.
Maintain awareness of relevant health and safety standards and ensure that health and safety processes are adhered to.
Provide clear communication to all staff to ensure engagement and clear understanding of the regulatory requirements.
Managing the training system (adding new hires to the training board, assigning training to new and existing hires, updating the training log, adding new documents to the training system).
Nonconformity management (raising NC/CAPA, writing NC and CAPA reports, managing action item timelines, and NC/CAPA due dates).
Syncing BioSpyder and BioClavis quality system.
Document Control (formatting, review, document life cycle management).
Technical writing for quality related documents.
Internal audits (perform internal audits and manage the internal audit schedule).
Learn lab procedures for services and manufacturing and work with the teams to ensure robust understanding of procedures and the impact of improvements.
Other duties as required.
essential qualifications
BSc degree in molecular biology or similar field.
Ability to work independently, as well as provide guidance to and work well with a multi-disciplinary team.
Excellent communication skills (oral and written), with the ability to maintain open communication with co-workers and managers.
Excellent attention to detail, ability to maintain accurate records.
Ability to send documents for authorisation using foxit and adobe.
Strong planning, organising and prioritisation skills.
Excellent analytical and problem-solving skills, with ability to interpret data.
Awareness of the Human Tissue Act.
Desirable qualifications
Knowledge of ISO 15189, GMP and UKAS.
Familiarity with molecular biology techniques.
Handling RNA.
Experience with next generation sequencing.
Familiarity with Monday.com and SharePoint.
Familiarity with document version control.
Right to Work
In accordance with UK legislation BioClavis Ltd, as an employer, has a legal responsibility to prevent illegal working and therefore must check that all employees are entitled to work in the United Kingdom (UK). Applicants must have the existing and ongoing right to work in the U.K. without restrictions as sponsorship for visas is not provided
BioClavis Ltd is required to see original documents evidencing right to work in the UK before commencement of employment and this is normally carried out at interview. Details will be provided in any letter of invitation to interview.
For further information about whether you require a visa and other visa routes please visit the GOV.UK website.