QA Associate

15 hours ago

Melbourne, Australia Avance Clinical Full time

**This is a rare opportunity to join our high performing QA team. If you are currently working for a CRO or Pharma organisation in GCP Quality Assurance, then we’d love to hear from you.**
***Adelaide, Melbourne, Sydney - office based**
***Who are we?**
We’re Avance Clinical an Australian based Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry.

**Why should you join Avance Clinical?**
We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team & support. We’ve doubled in size in the last 2.5 years and have promoted over 25% of our people in the last 12 months.

**The role**
The Quality Assurance (QA) Associate is responsible for supporting the development, implementation and maintenance of the quality assurance program and related policies and procedures to ensure compliance with Good Clinical Practices (GCP) and other regulations.

**Responsibilities**
- Conduct internal study audits (TMFs, Study Databases & CSR’s) to ensure compliance with applicable regulatory and organisational procedures
- Conduct internal process audits to verify compliance with internal processes and applicable regulatory requirements
- Assist with vendor audits and audits conducted by sponsors
- As required, contribute as a member of the investigational team for CAPAs
- Coordinate preparation, review and issue of Standard Operating Procedures (SOPs) to support and maintain Avance Clinicals’ quality systems
- Maintain an up-to-date knowledge of the latest requirements relating to GCP and regulatory requirements in Australia and overseas

***Qualifications, Skills and Experience**
- Bachelor’s degree in a life science field
- Minimum 2 years’ experience as a Quality Assurance professional operating in a GCP **OR**GxP environment with ICH-GCP training & knowledge of clinical trials from a non-manufacturing perspective
- Formal audit training or evidence based internal / study audit training
- Intermediate MS Office suite.

**What next?**
As a growing business we’re looking for likeminded people to join us - we hope that’s you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You **must** have full Australian working rights to be considered as we’re unable to offer sponsorship
- Please note this is an office-based position

Quality Assurance / QA / GCP / Adelaide / Melbourne / Sydney

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