Biological Analysis Specialist

1 week ago

Sydney, New South Wales, Australia beBeeMicrobiologist Full time $100,000 - $130,000

**Microbiologist Position Summary**

Aegros is a leader in the development of therapeutic plasma products. We are seeking an experienced Microbiologist to join our Quality Control team.

The successful candidate will be responsible for developing and performing microbiological and biochemical analysis of In process, finished product and incoming raw materials and utility samples.

This role offers a unique opportunity to contribute to the development and growth of our QC Organisation and be part of a multi-disciplined & multi-cultural fast paced team environment.

Job Description:

We are looking for a highly organised and focused individual who understands the importance of delivering on time and contributing to our success. The key responsibilities of this role include:

  • Conducting microbiological testing in accordance with approved procedures.
  • Assisting in setting up Micro and PC2 laboratory.
  • Performing 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 (SOP's, 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.

Requirements:

To be considered for this role, you will need to have:

  • 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.

Benefits:

This role offers a competitive remuneration package including annual bonus/opportunity to participate in our employee share option plan. You will also have the chance to work with global industry experts in a rapidly expanding company and be involved in the creation of a culture where innovation is welcomed, and success celebrated.

About Us:

Aegros is committed to providing therapeutic plasma products to those in need. Our mission is to put patients first through innovation.

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