Quality Assurance

3 weeks ago

City of Melbourne, Australia Avance Clinical Pty Full time

New role within clinical trials QA. If you have 2 years GCP / GxP experience & a passion for quality please apply

About the role

The Quality Assurance Assistant in QA Operations team 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.

Location

Melbourne CBD – office based 5 days per week.

Company

We’re Avance Clinical, an Australian based Contract Research Organisation offering specialised services supporting drug development for the pharmaceutical and biotechnology industry.

Benefits

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 23% of our people in the last 12 months.

Responsibilities

- Conduct study audits (Trial Master Files, Study Databases and Clinical Study Reports) to ensure that the study was conducted in compliance with applicable regulatory and organizational procedures.

- Conduct internal process audits to verify compliance with internal processes and applicable regulatory requirements.

- Assist with questionnaire‑based vendor audits.

- As required, contribute as a member of the investigation team for Quality Issues.

- Ensure QA process is completed in accordance with the defined timelines and supporting documentation are filed as per procedures.

- Maintain an up‑to‑date knowledge of the latest requirements relating to GCP and regulatory requirements in Australia and overseas.

- Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

Qualifications, Skills and Experience

- Bachelor’s degree in a life science field.

- Minimum 2 years’ experience in a GCP OR as a Quality Assurance professional operating in a GxP environment.

- Demonstrated ability to prioritise work, manage multiple priorities and deliver tasks on time with a high degree of accuracy.

- Good written and verbal communication skills with a demonstrated ability to communicate effectively with senior management and other departments.

- Demonstrated ability to work harmoniously and cooperatively with other people and to work independently without supervision.

- A proactive and enthusiastic team player who is willing to work in, and be supportive of, a positive and dynamic team culture.

- 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 in Melbourne CBD.

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