Australian Nuclear Science & Technology Organisation
Sterility Assurance Microbiology Spec.
Australian Nuclear Science & Technology Organisation, Lee Center, New York, United States,
Ongoing | Full Time | $111k - $125k +15.4% super
Relocation packages will be considered | Work-life balance
On-site Childcare Centre | Generous Maternity & Parental Leave Provisions
About the OpportunityThe Sterility Assurance and Microbiology Specialist is to coordinate the Sterility Assurance functions of Nuclear Medicine. This role will lead the Sterility Assurance and Microbiology function from a technical perspective and ensure compliance with local and international regulations for sterile pharmaceutical manufacture.
About YouThe ideal candidate will possess extensive knowledge in GMP pharmaceutical manufacturing with sound knowledge in aseptic processing, cleaning validation, sterile principles and microbiology. Demonstrated experience in quality risk management, root cause analysis and problem solving is essential. The successful candidate will have strong interpersonal skills and engage with a diverse group of internal and external stakeholders for technical collaboration.
Your Duties and Responsibilities
Subject matter expert for sterility assurance function for Nuclear Medicine business
Lead sterility assurance related investigations and risk assessments
Lead sterility assurance continuous improvement initiatives
Lead sterility assurance related validations including process simulation media fill, equipment qualification and facility certifications
Monitor and report on sterility assurance metrics and trends
Lead sterility assurance education programs across the Nuclear Medicine business
Oversee transition to revised PIC/s Code to GMP Annexe 1
Please click here to view the Position Description or click "Apply Now" to view.
About UsANSTO leverages great science to deliver big outcomes. We partner with scientists and engineers and apply new technologies to provide real-world benefits. Our work improves human health, saves lives, builds our industries and protects the environment. ANSTO is the home of Australia's most significant landmark and national infrastructure for research. Thousands of scientists from industry and academia benefit from gaining access to state-of-the-art instruments every year.
Benefits of Working with UsANSTO employees are passionate about what they do. We enjoy being part of an organisation making a difference in the lives of Australians.
We support and reward our employees through eligibility for:
Training, development and mentoring opportunities
Performance based salary increases
Work-life balance with generous leave entitlements and flexible conditions
If you want to join a world class organisation that's making a difference in the lives of Australians, apply now!
How to ApplyFor further technical information relating to this position please refer to the Position Description or contact Lee-Ann Carrasco on 0476 246 149. For all other queries please contact Talent Acquisition on +61 (02) 9717 3511.
To be eligible for appointment, applicants will require a security and pre-employment medical assessment.
All applicants must be Australian citizens.
In order to solve great challenges, we need great minds and great teams. At ANSTO, we understand that diverse teams produce better outcomes and we value the merit that a diverse perspective can bring to our team. We encourage people from diverse backgrounds to apply for our roles including Aboriginal and Torres Strait Islander people, primary carers, those with a disability, and women in STEM. ANSTO is a charter member of the Science in Australia Gender Equity (SAGE) initiative and is proudly taking action to create a gender-inclusive workforce.
#J-18808-Ljbffr
Relocation packages will be considered | Work-life balance
On-site Childcare Centre | Generous Maternity & Parental Leave Provisions
About the OpportunityThe Sterility Assurance and Microbiology Specialist is to coordinate the Sterility Assurance functions of Nuclear Medicine. This role will lead the Sterility Assurance and Microbiology function from a technical perspective and ensure compliance with local and international regulations for sterile pharmaceutical manufacture.
About YouThe ideal candidate will possess extensive knowledge in GMP pharmaceutical manufacturing with sound knowledge in aseptic processing, cleaning validation, sterile principles and microbiology. Demonstrated experience in quality risk management, root cause analysis and problem solving is essential. The successful candidate will have strong interpersonal skills and engage with a diverse group of internal and external stakeholders for technical collaboration.
Your Duties and Responsibilities
Subject matter expert for sterility assurance function for Nuclear Medicine business
Lead sterility assurance related investigations and risk assessments
Lead sterility assurance continuous improvement initiatives
Lead sterility assurance related validations including process simulation media fill, equipment qualification and facility certifications
Monitor and report on sterility assurance metrics and trends
Lead sterility assurance education programs across the Nuclear Medicine business
Oversee transition to revised PIC/s Code to GMP Annexe 1
Please click here to view the Position Description or click "Apply Now" to view.
About UsANSTO leverages great science to deliver big outcomes. We partner with scientists and engineers and apply new technologies to provide real-world benefits. Our work improves human health, saves lives, builds our industries and protects the environment. ANSTO is the home of Australia's most significant landmark and national infrastructure for research. Thousands of scientists from industry and academia benefit from gaining access to state-of-the-art instruments every year.
Benefits of Working with UsANSTO employees are passionate about what they do. We enjoy being part of an organisation making a difference in the lives of Australians.
We support and reward our employees through eligibility for:
Training, development and mentoring opportunities
Performance based salary increases
Work-life balance with generous leave entitlements and flexible conditions
If you want to join a world class organisation that's making a difference in the lives of Australians, apply now!
How to ApplyFor further technical information relating to this position please refer to the Position Description or contact Lee-Ann Carrasco on 0476 246 149. For all other queries please contact Talent Acquisition on +61 (02) 9717 3511.
To be eligible for appointment, applicants will require a security and pre-employment medical assessment.
All applicants must be Australian citizens.
In order to solve great challenges, we need great minds and great teams. At ANSTO, we understand that diverse teams produce better outcomes and we value the merit that a diverse perspective can bring to our team. We encourage people from diverse backgrounds to apply for our roles including Aboriginal and Torres Strait Islander people, primary carers, those with a disability, and women in STEM. ANSTO is a charter member of the Science in Australia Gender Equity (SAGE) initiative and is proudly taking action to create a gender-inclusive workforce.
#J-18808-Ljbffr