The Senior QC Analyst has the responsibility for ensuring that incoming goods, in process materials and final product all meet Ellume’s quality requirements. The Senior QC Analyst will conduct routine and non-routine analysis of raw materials and records and investigates out-of-specification and out-of-trend results and non-conformances. This role will work closely with the production teams by providing input into the quality plans for new products.

Duties and responsibilities

• Assist with the design and development of QC plans to verify the biological reagents and immunoassays that will be integrated into Ellume’s products.
• Assist in the drafting and maintenance of project management tools and cross-functional project review meetings.
• Perform and/or review results of in process QC testing.
• Calculating results and reporting of data, including trend analysis as required.
• Maintain and develop appropriate monitoring metrics for in process and final release activities.
• Reporting and communicating to QC Manager and other Ellume employees when required.
• Development of leadership skills.
• Meeting quality and safety standards.
• Perform final product release testing.
• Collaborate and contribute within multi-disciplinary teams to provide innovative solutions to technical problems.
• Present data at internal meetings, write reports, and prepare documentation including methods and SOPs.
• Perform complex data analysis to solve program problems or blockers.
• Other duties as assigned.

Education and Certification

Essential Qualifications:

• Degree / Diploma in Science or Engineering (or) – BSc in science preferred.
• Five years or more of experience working in a laboratory setting.

Desirable Qualifications:

• Experience in a regulated industry

Quality and Safety

All Employees and Contractors are responsible and accountable for:

• Compliance with workplace policies for Quality and Safety,
• Active participation in activities associated with the management of workplace health and safety.
• Active participation in activities associated with the management of quality.

Our Company

Ellume U.S.A. is a proud subsidiary of Ellume Ltd. (based in Brisbane, Australia). We are a Health Technology company that develops and manufactures rapid and accurate digital diagnostics for U.S. medical practitioners and consumers. We achieve this by applying the working practices of our parent organization through the integration of next-generation diagnostics, reader technology and software. Our products are distinguished by their simplicity of use, rapid time to result and connectivity.

• Our Vision - A world where people return to health as soon as possible.
• Our Mission - Through the creation of simple, accurate diagnostic tools and through the linking of the results of those tools to the best treatment, we help people to get better sooner and enjoy their lives.
• Our Purpose - To create rapid, accurate diagnostic tools that link people to optimal therapy.

The Ellume Way

“Making things great” is one of our most important values at Ellume. We work hard every day to create products that will enhance the lives of people in our community, our country, and all over the world. Doing things great is not an option at Ellume. Working here means making a commitment to uphold the “Ellume Way”.

• Make it great – we care about great products and general execution. The best we can possibly create.
• We are candid – with ourselves and with each other. Sometimes these conversations are hard, and we deal with those conversations thoughtfully and respectfully.
• We are a team – we believe in, support, listen to and respect each other. Together we will achieve great things!
• We can think – we value quiet contemplation and flying ahead of the plane. Thought experiments are the best experiments of all.
• We have a bias for action – thoughts are not our aim. Our aim is great products and great execution which improve millions of lives.
• We are bold – we are open to new approaches, strategies, and processes. Innovation is in our DNA and together we believe we can do the impossible.
• We are ambitious for the company – through success of the company, we all succeed; our customers, our partners, our shareholders, our communities, and ourselves.
• We celebrate – individual and team successes at every opportunity.
• We are driven – to make the future better by inventing it to be so.