Address
Form of work
SalaryResonance Health Ltd is an ASX listed TGA licensed Medical Technology and Services Company. Resonance Health, through its subsidiary Resonance Clinical (CRO Services Pty Ltd), provides high quality clinical trial services to the pharmaceutical and biotechnology industry. We are committed to delivering a quality service to our clients and we seek like-minded people to join our team.
About the Role:
This newly created role is responsible for ensuring compliance with quality standards and guidelines for all clinical trials conducted by CRO Services Pty Ltd. The primary focus of this role will be to develop and maintain document control processes, SOPs and QA processes, in addition to performing vendor qualification. This role also provides general administrative support to a small team.
What you will be responsible for:
With a dual reporting line to the Program Director and GM of QA & RA, the key responsibilities of this role include:
- Developing and maintaining QMS documents and processes for clinical trial services. This includes the development, review, approval, implementation and control of SOPs and associated internal documents.
- Developing SOPs, processes and documents to manage logistics, transport, storage and access of study equipment and supplies to clinical trial sites.
- Developing, implementing and controlling documents related to Local Sponsor management of internal processes and external vendors related to clinical trial conduct in Australia.
- Assisting with Supplier and Vendor Qualification.
- Managing the distribution, delivery, maintenance and use of medical equipment and supplies required for clinical trial conduct at trial sites.
- Providing general administrative support to the clinical trial team.
About You:
We are seeking someone with Quality Assurance knowledge and experience within the Clinical Trial and/or Pharmaceutical Industry (including testing laboratories) to join our team. You will have a formal qualification in either science or a related field, together with at least two (2) years of experience in Quality Assurance relating to ISO 17025 and GCP.
You will be skilled in writing SOPs and reviewing technical documents such as protocols and reports. You will have an excellent work ethic whilst enjoying connecting with a small, growing team.
Critically, your written and oral English skills will be of a high standard, as are your attention to detail and accuracy. You will be organized and able to prioritize, as you will need to move rapidly between tasks.
What we offer you:
- A part-time position in a growing company with an exciting vision.
- A friendly and happy team environment, working with talented and smart people.
- Floating Public Holidays, so that you can substitute any Public Holiday for another day of your choice.
- Broad flexible working arrangements to enable you to balance collaboration with your other life commitments.
- Market competitive remuneration.
- We promote internally and focus on the development of our employees.
