Quality Assurance Lead

Arbetsbeskrivning
As QA Lead You will develop, maintain, monitor and audit quality management systems and protocols that ensures compliance with regulation standards. You will be in charge of reviewing and approving and follow up on all quality assurance activities on-site. You will also be leading continuous improvement activities and training of laboratory personnel and other functions in quality standards and processes. You will work closely with the laboratory manager, technical experts, chief technicians and clinical experts.

Ansvarsområden
Develop and implement the Quality Assurance strategies.
Participate as a member of the laboratory’s management team.
Be the escalation point for all matters related to quality assurance and operate as a primary point of contact for QA matters internally as well as externally.
Approve Qualification and Validation processes of new laboratory procedures / methods as well as instruments.
Ensure that all departments and teams adhere to the principles, guidelines and practices of the QA strategy.
Manage training and continuous learning. Conduct and/or oversee internal QA training.
Represent QA in client meetings, and meetings with regulatory bodies.
Perform internal audits and approve audit responses.
Lead and delegate processes for deviations, CAPAs and change control.
Be point of contact and respond to external audits conducted by regulatory agencies.
Perform annual Management Review of the Quality System
Maintain necessary laboratory certifications.
Review and approve laboratory SOPs.


Kvalifikationer
This role is suited for someone with a quality mindset that thrives in an entrepreneurial environment. You are analytical and must be able to prioritize, work efficiently, be structured, and be results-oriented. We believe you have a couple of years experience from QA function; either from laboratory medicine or Quality Control experience from pharmaceutical manufacturing. Understanding of laboratory medicine and laboratory techniques is a great plus.

Moreover to be successful in this role we believe you have strong organizational and time management skills. Ability to communicate effectively at all levels of organization, clients and outside agencies. In addition, you have an outstanding ability to collaborate as the job involves cross- functional organizational environments.


Bachelors / Master’s degree in a Life Science related discipline
minimum of 10 years of QA experience
preferably in-dept knowledge of laboratory medicine / laboratory analytical processes
knowledge of the regulatory framework and ISO standard applicable.





Om företaget
ABC Labs was created in Spring 2020 in direct response to the unprecedented challenges of the coronavirus pandemic, as a handful of health tech entrepreneurs set out to establish rapidly scalable, state-of-the-art PCR and ELISA testing. Initially built and deployed over seven weeks, ABC has consistently represented up to 25% of all national testing for Covid-19 with over 3 million tests completed.

Our culture is defined by speed, agility, and innovation without ever compromising the highest standards of quality. ABC was first in Sweden to set up mass screening for both the Delta and Omicron variants and the first in Europe to launch tests for measuring T-cell immunity.

We believe the pandemic has changed diagnostics and healthcare forever. Looking towards the future, we are investing heavily to create solutions that make testing affordable, accessible and readily available.