Date Posted: Friday, 3 November 2023

Senior Quality & Regulatory Affairs Associate

Organisational Context

The National Reference Laboratory (NRL) operates as a division of St Vincent’s Institute (SVI) whose mission is to produce world class science: inspired by discovery, driven by purpose. It is located in the St Vincent’s Hospital campus which lends NRL unique opportunities to collaborate with clinicians, researchers, and academics as well as work together on joint campus initiatives such as the SVI Biobank. Whilst given natural free rein to deliver its specific scientific activities, NRL is an integrated component of St Vincent’s strategic objectives and as such the NRL works closely with SVI in this regard. NRL was established as part of the Australian Government’s HIV and AIDS strategy in 1985. Contracted by the Department of Health and licensed by the Therapeutic Goods Administration (TGA), NRL supports collaborative scientific partners worldwide in the promotion of accurate diagnosis and management of human communicable diseases, including HIV, HCV and HTLV. It does this by providing specialised services, including pre- and post-market evaluations of test kits, provision of quality assurance programmes to laboratories, specialised testing services, and consultation, education, and training for laboratories nationally and internationally. NRL holds the unique position of being the only organisation world-wide that delivers this full suite of services, and with significant future opportunities to significantly grow NRL’s market and services globally.

The role

NRL is currently seeking an organised, enthusiastic and self-motivated Senior Quality Associate and Regulatory Affairs Associate. This position is a full-time, 12-month position to support the accreditation projects at NRL.

The primary purpose of this position is to provide Quality and Regulatory Affairs knowledge and deliver quality projects including support of the ISO 13485 certification project, enable the translation of research discoveries and/or product/service development by achieving regulatory compliance and the ISO 20387 certification project for accreditation of the SVI Biobank.

In association with the Quality and Regulatory Affairs Manager, the incumbent will execute Regulatory Affairs and QMS activities, support projects and provide quality support in the translation of research discoveries, developments and other new work into routine operations or for commercialisation. Compliance with industry legislation, codes, standards and guidelines will be enabled in order to ensure regulatory registration, accreditation and certification as required.

For full details of the job responsibilities, please refer to the Position Description.

Who we are seeking:

Our ideal candidate will have:

Essential

• Tertiary qualifications in pharmaceutical, medical or biological science
• At least 8 + years’ experience working in a GMP, medical device or cell therapy environment, with a strong understanding of quality control procedures and relevant standards
• Proven experience in a quality role ideally in a scientific laboratory and/or manufacturing facility, responsible for maintaining ISO 13485, NATA, regulatory affairs experience including TGA GMP registration and/or other accreditation relevant to a laboratory environment
• Demonstrable leadership abilities and ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports
• Successful implementation of ISO 13485 and inclusion of IVDs on the ARTG.
• Ability to implement the requirements of ISO 20387 to the BioBank’s operations.
• An understanding of key quality concepts and their in-practice application.
• Experience and proficiency in using and maintaining quality management systems.
• Prior experience in fulfilling organisational and liaison functions, including from a non-quality function such as administration or office management.
• Strong written and interpersonal skills.
• Ability to implement new software approaches to best achieve NRL’s aims.
• Ability to develop processes and systems that improve operational efficiency.
• Proficient with all Microsoft Office packages with advanced skills in Word, Excel and PowerPoint highly desirable.
• Experience working within a research, pathology or health environment.

To be considered you shall be required to provide evidence you have permanent working rights in Australia or hold a relevant working visa to work full-time hours.

Salary Range:  $102,149 – $108,429 per annum plus 11% superannuation. In addition, we offer up to $15,900 FBT exempt salary packaging and up to $2,650 FBT exempt meals and entertainment packaging.

Salary applied will be dependent on successful candidates’ current level, experience and qualifications.

Position Description: Please click on the apply button to view the full position description and selection criteria.

Further information: Lucy Waddell, Quality and Regulatory Affairs Manager: [email protected]

To apply: Please click on the apply button. All applications addressed to Lucy Waddell should include the following:

– Current CV; and

– Cover letter addressing the selection criteria

Applications Close: COB, Thursday 30 November 2023. However, applications will be reviewed as they are received and the job may closer earlier than the advertised closing date.

Date Posted: Thursday, 12 October 2023

Administration Officer

Organisational Context

The National Reference Laboratory (NRL) operates as a division of St Vincent’s Institute (SVI) whose mission is to produce world class science: inspired by discovery, driven by purpose.

The Role

NRL is currently seeking a full time Office Administrator with a strong work ethic and can-do attitude to help maintain the NRL office systems and provide high level support to NRL teams.

The role involves general administration duties which will ensure the smooth functioning of the office such as:

• Monitoring and ordering replacement office and laboratory supplies
• Liaison with and coordination of office suppliers and service providers
• Agenda preparation, taking and circulating meeting minutes
• Liaising with the People and Culture team

Who we are seeking:

Our ideal candidate will have:

• Experience in providing administrative support
• Strong written and interpersonal skills
• Proficiency with all Microsoft Office packages with advanced skills in Word, Excel and PowerPoint
• Strong attention to detail and accuracy
• Excellent organisational skills, able to multitask and prioritise work during busy periods

To be considered you shall be required to provide evidence you have permanent working rights in Australia or hold a relevant working visa to work full-time hours, as well as being fully vaccinated for COVID-19. You will also be asked to undergo a police check.

Salary Range: $69,604 to $73,864 per annum plus 11% superannuation. In addition, we offer up to $15,900 FBT exempt salary packaging and up to $2,650 FBT exempt meals and entertainment packaging.

Salary applied will be dependent on successful candidates’ current level, experience and qualifications.

Position Description: Please click on the apply button to view the full position description and selection criteria.

Further information: Lucy Waddell, Quality and Regulatory Affairs Manager ([email protected] )

To apply: Please click on the apply button. All applications addressed to Lucy Waddell should include the following:

– Current CV; and

– Cover letter addressing the selection criteria

Applications Close: COB Friday 17 November 2023, however, applications will be considered as they arrive, and the position may be filled ahead of the closing date.