Santa Monica, CA

Clinical Quality Officer - (Job Ref: 23I/CQON)

$80K - $125K

Randox Health California LLC are growing their team at our Clinic / Laboratory in Santa Monica. We are seeking a Clinical Quality Officer to oversee the Quality Management System to ensure compliance with CLIA and other regulations in California. This is a key role and will involve the updating of SOPS and procedures as well as conducting internal audits to maintain compliance.

The Role:

• Assist in the management of non – conforming work identified and ensure that NPCs in the RESOND database are progressed in line with documented procedure.
• To participate in quality audits, in particular internal CLIA (ISO17025, ISO15189 and GCP) or any other audits.
• Assist in the management of internal audits by progressing CAPA Plans in accordance with documented procedure.
• To assist in the writing of new Standard Operation Procedures and work instructions within the department.
• Assist in the monitoring of customer queries and trending of outcome of the query.
• Attending department quality and technical review meetings, taking minutes and keeping notes.
• Participate in special projects and initiatives as requested by the RCLS quality manager or RCLS deputy heads of department.

Please note that this job description is intended as a guideline - new duties and responsibilities will be incorporated as a matter of custom and practice as the role evolves

The Candidate:

Essential:

• Educated to Degree level (Life science degree desirable) or relevant experience.
• Experience in preparing and performing internal audits
• Proficient in use of Microsoft Packages Word, Excel, PowerPoint etc.
• Excellent verbal and written communication skills.
• A high level of self-motivation
• Excellent organizational skills with an eye for detail and the ability to prioritize
• Maintain professional membership of national and international societies such as IGMS when required.

Desirable:

• Previous experience in CLIA internal auditing.
• Experience in a clinical diagnostics laboratory.

About Randox:

An international company operating in over 145 countries that continues to have unparalleled growth, Randox Laboratories has been the heartbeat of the UK’s National COVID Testing Programme throughout the pandemic. In early 2020 Randox recognised the threat from COVID-19 and, based on over 40 years of diagnostic experience, quickly developed a test to accurately identify the virus. Testing at scale commenced within weeks to support the UK’s National Testing Programme and private clients alike. Through the enormous effort and commitment of its staff Randox is currently operating at a capacity of 180,000 COVID-19 samples per day, making it the most productive laboratory in the UK and Ireland and amongst the very largest in Europe.

Additionally, as a world leader in diagnostics for clinical healthcare, toxicology and food security, our expertise and product portfolio have assisted laboratories across the world in improving health and saving lives. Our global success is a result of our pioneering products and the commitment & skill of our workforce, which continue to grow exponentially.

Central to the Randox ethos is our drive and determination to improve healthcare worldwide and every one of our talented staff play a role in this. In order to serve our growing international markets, we require high calibre applicants with scientific, engineering, software and broader business skills – including sales, marketing, logistics, finance and many more. Join the Randox team and play your part in improving the health of millions.

Randox Laboratories Limited is an Equal Opportunities Employer.