Address
Form of workAbout Baxter
Baxter provides a broad portfolio of essential Renal and Hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services.
The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Baxter and Hillrom are uniting to meet the challenges of a rapidly-evolving healthcare landscape. Together, we will enable care efficiencies, improve care outcomes and broaden access to care in the hospital, home and alternate care settings
The Role
A great opportunity has become available for a Senior Sterility Assurance Specialist to join a critical area of the business. We are looking for a high performer with a wealth of experience to join our team working anywhere across our 7 different aseptic compounding sites within ANZ. You will be responsible for providing technical expertise and supporting ANZ Compounding sites on all Sterility Assurance aspects to ensure that all sites maintain a robust Sterility Assurance and environmental control and monitoring process that complies with Baxter’s Global Quality and local TGA Regulatory requirements.
Key responsibilities
- Support to site Environmental Monitoring and Media Fill Programs
- Investigation and identification / follow-up of corrective actions relating to Micro Out-of-Limit results
- Interact with the TGA during GMP Regulatory Inspections
- Maintenance of the Microbial Control Strategy
- Collating & analysing/trending EM data
- Subject Matter Expert for IT systems for Sterility Assurance: NOVAtek, CQI
- Liaison with Toongabbie Micro Lab as needed
- Initiating and supporting continuous improvement initiatives relating to Sterility Assurance program
- Performing impact and risk assessments for Change Controls relating to Sterility Assurance
- Providing training on Sterility Assurance related topics as needed
- Participate Internal, Corporate and Regulatory Inspections as required, including identifying & coordinating relevant follow-up actions.
- Drive and support improvement and standardization of the QMS, including coordination of continuous improvement activities.
- Other duties in support of Compounding Quality Systems as required, including support to Regional/Global Compounding
Qualifications, Skills, Knowledge and Experience
- A microbiology or other life sciences graduate with significant with experience of aseptic processing/compounding and understanding of classified cleanrooms / Sterile environments.
- At least 5 years’ experience in implementing environmental control programs and OOL investigation and correction
- Pharma Industry / TGA experience or TGA accredited Microbiology laboratory
- Experience in data collation and analysis
- Experience in implementing and maintaining quality systems in a regulated environment, including document control, change control, nonconformance management, validation.
Desirable skills
- Experience in developing and delivering training
- Experience in validation of microbiological methods e.g. disinfectant validation, recovery studies
- Experience interfacing with regulatory inspectors/auditors
Why Baxter?
At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively.
Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.
We are proud to be recognised among the top 120 companies for the seventh consecutive year as an Employer of Choice for Gender Equality for delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of women at work. We are also pleased to be the winner of the 2021 & 2019 Women in MedTech Champion Company Award.
Baxter recognises the importance of flexible work arrangements, and we offer remote and hybrid arrangements so that our employees can have work/life balance and support their health & wellbeing.
We are proud to introduce BaxFlex, where we maintain our workplace flexibility philosophy while also realising the benefits of connecting in-person on-site.
Situated in Western Sydney, and featuring and onsite cafeteria and café, gym, we offer a dynamic and future focused work environment offering workplace 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
