Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives. THE ROLE
We are looking for a Laboratory Quality Systems Associate to join our Laboratory Services team where you work with the Laboratory Quality Systems Lead to ensure the effectiveness and maintenance of the Laboratory Quality Management System. In addition, you will be responsible for ensuring that all documentation is accurate and reflects the work and testing required by the sponsor protocol for all studies being run by Simbec-Orion’s Laboratory Services. You will help to promote a culture of continuous quality improvement at Simbec-Orion. KEY ACCOUNTABILITIES
SKILLS REQUIRED ESSENTIAL
- Ensure that work performed adheres to good practice regulations and guidelines.
- Document all procedures that are undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy.
- Serve as a key part of the Laboratory Services quality management structure, liaising with the other Laboratory Services managers and Laboratory employees to ensure successful delivery of customer projects.
- Support with updates and roll-out of new SOP’s/Work instructions related to quality and subsequent training of all employees within Laboratory Services with quality associated training requirements.
- Support the ISO17025 compliance program and Quality improvements within the Laboratories.
- Support the Laboratory to ensure that work carried out meets GxP and GCP for Laboratories.
- Assist with Internal audits.
- Maintain personal training records to demonstrate competency and ensure compliance with audits.
- Science degree or equivalent
- High level of attention to detail
- Excellent computer skills within O365 programs such as Word and Excel
- Ability to work in line with standard operating procedures and work instructions
- Ability to generate and maintain effective working relationships with team members and managers
- Ability to work in a fast-paced environment
- Strong interpersonal, communication, organisational and time management skills
- Ability to handle multiple tasks at one given time
WHY YOU SHOULD JOIN US
- Previous experience of working within a Clinical Research Organisation
- Previous experience working in a regulated environment (IS0 17025 15189 or MHRA GCP)
Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.
We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.
With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.