Sterility Assurance Associate

About Us:

We have a proud heritage of nearly 50 years borne out of the Victorian College of Pharmacy in Parkville, Melbourne, Australia as a true biotechnology organisation helping develop and scale up new and emerging medicines and technologies many of which are part of the mainstay in Australian healthcare today.

IDT Australia is a publicly-listed Australian pharmaceutical developer and manufacturer, based in Boronia Victoria. Partnering with pharmaceutical leaders IDT specialises in the development and the commercial manufacture of high potency active pharmaceutical ingredients (API) and finished drug products for local and international markets. 

At IDT we value Ownership & Accountability, Trust & Integrity, Adaptability, Teamwork & Collaboration, Innovation & Problem Solving. 

The Role:

We are seeking a professional Sterility Assurance Associate to join our Microbiology team.  You’ll be joining a small highly capable team that will provide you with a well-rounded hands on opportunity to continue to grow all aspects of your pharmaceutical industry career. 

The key function of this role is all things sterile, you will need to support Annex 1 remediation, oversee aseptic practices, provide input into media challenge strategies, and provide input from a Sterility Assurance subject matter expert perspective into any deviations associated with the sterile area. 

The role also supports environmental monitoring program during sterile filling and at the end of sterile manufacturing and is involved in the development and validation of new methods as well as training and yearly aseptic requalification assessments of sterile filling operators.

Extensive cross functional interactions with Quality and Operations, Validation and Tech Transfer, Supply Chain, Engineering, Finance and Business Development groups and other staff up to and including clients. 

Key responsibilities include:

• Author risk assessments, validation, qualification protocols and reports of the facility, utilities, equipment, process, personnel, environmental monitoring and media fills.
• Governance, trending, and reporting of environmental and personnel monitoring.
• Provide QA oversight and SME input of Quality standards and system aligned with the Sterility Assurance function.
• Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance program.
• Recognizes and assures conformance to regulations applicable to Sterility Assurance. Serve as Sterility Assurance SME during routine audits by regulatory agencies, internal corporate auditors, and external auditors.
• Provide microbiological/Sterility Assurance expertise including, but not limited to, SOPs, change control, deviations and validations.
• Responsible for the microbiological/Sterility Assurance risk assessment.
• Perform and/or participate in root cause investigations for microbiological and manufacturing nonconformances.
• Assist in investigation, review and finalisation of OOS, deviation, non-compliance complaint and recall issues and associated corrective actions (specifically associated with microbiological aspects of process and product quality) in order to verify their effectiveness at preventing repeated incidents.

Background and experience:

The person holding this position should have:

• Bachelor’s degree in microbiology, Biology, or related science.
• 2+ years of work experience in Sterility Assurance.
• Proven leadership/supervision and experience within an aseptic or sterile manufacturing site. 
• Expert knowledge in aseptic technique, clean-room behaviour and practice, cleaning methodologies, and risk assessments.
• Knowledge of aseptic and terminal sterilization processing.
• Knowledge of contamination control practices.
• Knowledge of FDA cGMP, EU Annex-I, ISO 14644-1 standards.
• Sound written and verbal communication skills to help construct scientific reports.
• Requires flexible work arrangements from time to time to support key activities for testing and projects.