Quality Assurance Associate Role
The role of a Quality Assurance Associate is pivotal in ensuring the quality and integrity of clinical trials. This position supports the development, implementation, and maintenance of quality assurance programs to guarantee compliance with Good Clinical Practice (GCP) regulations.
Responsibilities:
* Conducting internal study audits for compliance, including review of Trial Master Files (TMFs), Study Databases, and Clinical Study Reports (CSRs).
* Performing internal process audits to ensure adherence to established procedures.
* Assisting with vendor and sponsor audits to verify compliance with regulatory requirements.
* Contributing to Corrective Action Preventive Action (CAPA) initiatives as part of the investigational team.
* Preparing, reviewing, and issuing Standard Operating Procedures (SOPs) to maintain quality systems.
* Staying up-to-date on GCP and regulatory requirements domestically and internationally.
Requirements:
* A Bachelor's degree in a life science.
* At least 2 years of experience in GCP/GxP with ICH-GCP training.
* Formal audit training or experience.
* Proficiency in Microsoft Office.
Benefits:
This opportunity offers a chance to work in a supportive environment that values honesty and respect. Our team has seen significant growth, with over 25% of staff promoted within the last year.
Next Steps:
Interested candidates should submit their CV and cover letter as one Word document. Please note that full Australian work rights are required, and sponsorship is not available. This role is office-based.