Microbiology Analyst

5 months ago


Old Toongabbie, Australia BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Microbiology Analyst**

**The Role**

An excellent opportunity now exists for an enthusiastic professional to join the Microbiology Laboratory on a 12-month fixed -term contract working Tuesday
- Saturday on day shift. This position is an integral part of the Quality Assurance (QA) team, responsible for the complete range of microbiological and environmental testing of plant and products to GMP standards, in order to meet regulatory requirements and the companies master production schedule.

The primary job role of the Microbiology Analyst is to perform the day-to-day microbiological sampling and testing of raw materials, finished products and environmental testing. This position involves working in a fast-paced environment and will be suitable for an individual who prides themselves on the level of accuracy in their work. You will work as part of an experienced and dedicated team.

**Key Responsibilities**
- Your core responsibilities will include, however will not limited to:

- Execute testing and Assist the Microbiology Supervisor to meet quality specifications and standards, review test results and have appropriate action strategies in place for non-conformances to ensure GMP and GLP requirements are met.
- Perform and be proficient in all testing in the wet and dry areas of the Manufacturing facility and Pharmacy Services. This includes pre sterilisation bioburden testing of product, raw materials, microbial identifications and microbial ingress testing.
- Environmental monitoring throughout Baxter operations. Enumerate and trend environmental monitoring from Class A, B, C and D environments. Monitor and review test results and have appropriate action strategies in place for non-conformances to ensure GMP within clean room areas.
- Coordinate the validation of Pharmacy operators and processes: sterile media fills for operator and processes, aseptic gowning and chemical accuracy testing.
- Ensure all testing is performed and compiled for critical work orders, validations and that manufacturing environments have been tested and are available for handover following shutdowns and critical systems work. Agreed timing and standards must be met.
- Perform water testing on non-distilled and distilled water throughout the manufacturing facility as per routine sampling and investigational monitoring.
- Assist in developing and recommending inspection and sampling techniques, quality control plans, testing and analysis procedures to ensure GMP quality specifications and standards are met for QA microbiology functions in Manufacturing and Pharmacy Services.
- Maintain close liaison with Manufacturing, Pharmacy Services and QA staff to communicate test results and to assist in adherence to standards and process control.
- Perform other duties as may be required by Microbiology Supervisor.

**Essential Skills & Qualifications of the role include**:

- Relevant tertiary qualification in Microbiology (Bachelor's degree Microbiologist, Science and other related education)
- Proven skills in environmental monitoring in a manufacturing environment, preferably in pharmaceutical or other regulated industry
- Proven attention to detail and accuracy in following procedures, documentation and data logging.
- The ability to work with statistics and relevant computer packages.
- Intermediate computer skills working with Microsoft office.

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**Desirable Skills and Qualifications**:

- 2 years+ experience in laboratory and environmental microbiology, preferably in pharmaceutical or other regulated industry

**Benefits & Culture**:
As an Employer of Choice for Gender Equality and winner of the 2019 Women in MedTech Award, Baxter ANZ is focused on being a best place to work. Situated in Western Sydney, and featuring and onsite subsidized cafeteria and café, gym, we offer a dynamic and future focused work environment offering work place flexibility, additional annual leave and a strong value driven culture.
- Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law._

**Reasonable Accommodations**