QA Microbiologist

Sabre Medical is dedicated to designing and delivering reliable and innovative packaging solutions for our customers' medical devices, specialising in crafting custom-designed packaging solutions. Our site includes four cutting-edge Class 7 and 8 cleanrooms on-site. These are equipped with the highest quality machinery, equipment, and technologies. We employ over 30 people in our Quality, Design Engineering, Facilities and Production teams and are continuing to grow.
We work with startups and help their R&D in bringing new and innovative medical device technologies to market. This requires an extensive range of testing and validation, using bespoke equipment and machines
We take pride in our ISO 13485 accreditation and are conveniently located in Lane Cove West NSW 2066.
Responsibilities:
Plan, conduct and report environmental monitoring of cleanrooms (at rest and in-process, including contact plates, settle plates, active air monitoring, NVP monitoring and operator monitoring),
Ensure adherence to microbiological quality standards, validate testing methods, and maintain accurate documentation of test results,
Troubleshoot and investigate microbiological issues, assist with implementing corrective actions,
Assist with training activities
Collaborate with other departments to address and communicate findings on microbiological concerns,
Plan, conduct and assist with change order (ECO) activities and documentation,
Plan, conduct and assist with CAPA investigation (NCR) activities and documentation,
Provide subject matter and expertise during internal audits and external regulatory audits.
Experience and Qualifications
Tertiary qualification with minimum bachelor level education in a science, majoring in Microbiology, biological science, or biochemistry,
At least two (2) years of Post Graduate experience in a TGA regulated manufacturing environment,
English with strong written and oral communication skills
Computer Literate use of statistical programs
Team oriented skills for problem resolution and implementation of projects
Attention to detail, meticulous ac