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SalaryRole : Microbiologist
Reporting to the Quality Control Manager, this newly created Microbiologist role is an important addition to our expanding team here in Sydney as we experience rapid growth across the organisation. You will be developing and performing microbiological and biochemical analysis of In process, finished product and incoming raw materials and utility samples. We are looking for a highly organised and focused team player who understands the importance of delivering on time and contributing to our success...!!!!
Responsibilities
- Conducting microbiological testing in accordance with approved procedures.
- Assisting in setting up Micro and PC2 laboratory.
- Performimg standard routine tests on products, materials, and generating laboratory results, using a range of analytical and microbial techniques such as sterility, isolator, endotoxin and bioburden testing.
- Environmental monitoring of the production facility, including viable, non-viable and utilities testing such as water and compressed gas sampling.
- Assisting in checking of assays, result entry and verification of assay paperwork
- Maintenance of QC documentation, training records and handling of Investigations and Deviations
- Ensuring all samples in the QC laboratory are documented as per approved procedures
- Assisting in updating and reviewing documentation (SOPs, Test methods and Specifications)
- Assist in validation and qualification of microbiological test methods and equipment qualification
- Support the team to ensure that the testing performed in each department are prepared and executed in accordance with GMP and assisting in technical issues and trouble shooting. Assist in root cause analysis and implement CAPA
- Calibrating and maintaining laboratory equipment and ordering and maintaining stock of reagents, consumables
- A minimum of Bachelor of Science degree or equivalent
- A minimum of 2 years experience in microbiological testing and analysis in QC laboratory as an analyst in pharmaceutical or equivalent industry
- Technical writing skills and record keeping
- Excellent knowledge of Microsoft office including word, excel ,PowerPoint etc
- An understanding and experience of quality systems and the need to develop and follow SOPs, particularly in a cGMP environment.
- Cleanroom and/or sterility testing and Endotoxin testing experience
- Exposure in cGMP manufacturing environment
- Good verbal and written communication skills;
- Knowledge of relevant regulatory requirements (FDA, EMA or TGA)
- Knowledge of biological separation technologies and processes desirable but not essential
- Protein chemistry and associated analytical biological assays desirable but not essential
Aegros is Latin for Patient. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life-saving therapeutic plasma drugs is a human right, not a privilege. In a nutshell, our mission is to put the patients first through innovation.
Over 30 years, we have developed our HaemaFrac ® process, which enables countries to turn the human plasma they collect into life-saving hyperimmune products.
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