Quality Assurance Officer-microbiologist

Summary

Full-Time, 2-Year Contract

At the South Australian Health and Medical Research Institute (SAHMRI), we are committed to achieving innovative, ground-breaking health and medical research that fundamentally improves the quality of life for all people.

An exciting opportunity is available for a Quality Assurance Officer
- Microbiologist to join SAHMRI supporting the Molecular Imaging and Therapy Research Unit (MITRU). This position will work closely with the MITRU Quality Assurance Manager to ensure MITRU’s radiopharmaceuticals are manufactured according to procedures and are compliant with the requirements of Good Manufacturing Practice (GMP) and the Therapeutic Goods Administration (TGA). The Quality Assurance Officer will support with microbiological test method validation, environmental and bioburden monitoring programs, aseptic process validation, management of out-sourced sterility testing and other systems which contribute to MITRU's microbiological contamination control strategy.

About the role

Key responsibilities include:

- Investigate, troubleshoot and report microbiological issues to assist the determination of root causes and to define effective corrective and preventative actions.
- Monitor, report on and improve the risk-based environmental monitoring and bioburden monitoring programs.
- Provide microbiological Subject Matter Expert (SME) input as part of change management and quality risk management processes.
- Assist in planning, documenting and implementing qualification and validation activities, particularly those that impact aseptic processes and sterility assurance.
- Plan, define and/or review microbiological test method validation, whether conducted in-house or out-sourced to contract microbiological laboratories.
- Review, validate and improve the operator gowning and facility sanitation / disinfection processes.
- Assist with investigations associated with process deviations, Corrective and Preventative Actions (CAPAs), out-of-specifications (OOS), non-conforming product and customer complaints.
- Assist with the supplier qualification of contract microbiological laboratories, including supplier audits.
- Support trend analysis and periodic product quality reviews.
- Assist with ensuring that MITRU personnel are inducted into the requirements of the Pharmaceutical Quality System (PQS) related to their own roles and responsibilities and provide training as necessary, particularly where microbiological Subject Matter Expert (SME) input is required.

About You
- Degree in Science majoring in microbiology, or highly similar tertiary qualification.
- Some experience working under a quality management system in a highly regulated environment is advantageous.
- Highly ethical and committed to quality, data integrity, GMP and safety.
- Good technical and scientific judgement.
- Proficient in analysing data sets, conducting statistical analysis and report writing.
- Well-developed analytical skills with the ability to develop practical solutions using a risk management approach.
- Excellent verbal communication skills including confidence in giving presentations to small groups.
- Meticulous in the conduct of practical and written work.
- Self-motivated and proactive with a focus on continuous improvement to support the achievement of best practice.
- Committed to undertaking continued professional development.
- Collaborative, flexible and positive approach to working with MITRU personnel and SAHMRI’s researchers.
- Sound time management and project planning skills.
- Good computer literacy with experience working with the Microsoft Office suite of programs. Experience with statistical programs and PowerBI advantageous.

Special Requirements
- Some out of hours work may be required.
- DCSI Employment Screening and Police Checks may be required.
- This position requires a pre-employment medical examination to determine suitability for the physical requirements of the role.
- The person must hold or commit to acquiring a relevant radiation licence from the South Australian Environment Protection Authority (EPA) in a timely manner (less than six months).

As a not-for-profit organisation, SAHMRI employees can access salary packaging options up to $15,900. Salary packaging lets you pay for things like the everyday costs of living with money from your salary before tax. This reduces your taxable income, meaning you could pay less tax and take home more of what you earn. For more information on salary packaging please see the Maxxia website.

For a copy of the position description, please click here.

Applications close: Sunday 27th October 2024
- Aboriginal and Torres Strait Islander people are strongly encouraged to apply_
- SAHMRI is a member of the Athena SWAN Science in Australia Gender Equity program. We have been awarded Bronze status for our commitment to advancing the careers of women, trans and gender diverse individuals in STEMM._

Equity & Diversity at SAHMRI

At SAHMR