QA Specialist - Deciphex : Job Details

About the Company

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps cancer patients get timely and accurate diagnosis.

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 100 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter and Chicago and are expanding our team throughout the world.

We are software developers, clinical specialists, artificial intelligence engineers, operations professionals and so much more, all working as one team to support our customers and patients.

We are looking for highly motivated & individuals who are excited to take on challenges and value making a difference in their day-to-day work to join our team!

Our company is seeking a Quality Assurance Specialist to join our team, with a focus on Good Laboratory Practice. The ideal candidate will be responsible for ensuring that all GLP service and operations is of high quality, meets customer requirements, and complies with regulatory requirements.

Read more about Deciphex here and more about our incredible team on our Careers Page here

About this Role (Responsibilities):

* Hybrid role working both on-site in Naperville and from home.

* Support scanning operations in USA, Canada, UK and Europe

* Develop and implement policies and procedures to meet GLP requirements ensuring quality and integrity of test data related to non-clinical safety studies

* Collaborate closely with Laboratory Operations ensuring quality and integrity of test data related to non-clinical safety studies is adhered to.

* Closely collaborate with customer service and computer system validation teams on projects and activities as required.

* Manage quality processes including planned deviations, non conformances, change controls, CAPA, document reviews and incident management for the team.

* Collaborate with cross-functional teams to identify and resolve quality issues and implement process improvements.

* Execute internal audits of operational processes, systems, facilities and also vendor/supplier audits to ensure compliance with regulatory requirements and company standards.

* Facilitate customer audits of our processes (on-site or remote) and coordinate post audit activities with our customers i.e. CAPAs, document updates etc

* Support regulatory audits as required for example, FDA, MHRA

* Conduct GLP requirement training sessions for employees and stakeholders.

* Foster a culture of quality and compliance within the test facilities.

* Ensure compliance with new and updated GLP regulations and industry standards

* Provide QA support to non-GLP activities as required on site by management

* Support any other duties as assigned by quality management

* Be a strong advocate to continuously improve the process inline with applicable requirements and best practices.

* Periodic traveling will be required to Canada, UK and Europe, up to 10% travel will be required

* Training required for the role may include ISMS, GLP, DocuSign and GDPR/HIPAA awareness.

About You (Skills and Experience):

* Bachelor's degree in Computer Science or Life Science industry

* At least 5 years of experience in GLP environment

* Strong knowledge of GLP regulations and current guidelines such as 21 CFR 58, 21 CFR 11, OECD Principles of GLP and GAMP 5 second edition

* Experience with GLP software validation and verification

* Experience with digital pathology is an advantage

* Knowledge of AI cloud computing, electronic data archiving is desirable

* Excellent communication, collaboration, and leadership skills

* Strong problem-solving and analytical skills

* Ability to work under pressure and meet tight deadlines

* Certification or professional training on GLP is an advantage

What are the benefits of working with Deciphex?

* A true sense of meaning in your work by contributing to better patient outcomes.

* The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.

* A chance to work on exciting and challenging unique projects.

* Regular performance feedback and significant career growth opportunities.

* Competitive salary with performance based annual increments.

* A highly collaborative and supportive multi cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the traveling community or any other classification protected by applicable law.