Production Assistant SpeeDx Pty Ltd location Sydney.

About us SpeeDx Pty Ltd is dynamic, rapidly growing company with a strong portfolio of technology at the cutting edge of molecular diagnostics. With our headquarters in Sydney, we are launching our technology into the market and have a pipeline of research and in vitro diagnostic assays. Our well-equipped offices and laboratories are centrally located at the Australian Technology Park in Eveleigh (Sydney) and are easily accessible by rail.

About the role we have an exciting opportunity for a Laboratory Assistant to join our Production team.  This position will support manufacturing activities and the development of diagnostic products in a strictly regulated environment. The role offers a true work/life balance and at SpeeDx we believe our employees are pivotal to our success and reputation.

Your primary responsibility will involve assist in manufacturing IVD products compliant with ISO13485, CFR 21 Part 820 & cGMP. Generation of Quality Management System documentations. Planning, performing, interpreting and recording experiments and formulating next steps based on experimental results. Verification and validation of new products and new processes. Developing test protocols that effectively test the design requirements and challenge the product performance.

Writing standard operating procedures and validation document. Inspecting raw materials and production consumables. Material handling and general production duties. Assist in manufacturing procedures, such as labelling, filling and packing. Preparation of laboratory reagents. Identify and investigate root cause of test anomalies involving product failure, production errors and claims avoidance.

Conducting risk assessments. Perform testing and data analysis and maintain activity records. Work according to the organization’s laboratory safety, health and environment standards. Perform general laboratory duties. Perform general housekeeping duties.

To be successful in this role you will require Skills & Experience in or similar to the below qualifications BSc or equivalent. Working knowledge of laboratory and QMS environment. Previous experience with qPCR is required. Solid time-management skills and ability to work under pressure. Excellent communication skills in both written and verbal. Great interpersonal skills and team player attitude. Have keen and diligent work ethic with good people skills to work within this enthusiastic team.