Job Title: Quality Assurance Lead
We are seeking a highly skilled Quality Assurance Lead to join our team in an Australian contract development and manufacturing operation specialising in nucleic acid products. This is a fantastic opportunity for someone looking to step up their career with a dynamic organisation that is growing rapidly.
The Quality Assurance Lead will be responsible for designing and implementing a Quality Assurance framework to support laboratory work activities across Production and QC teams. They will establish and maintain quality policies, procedures, and documentation, ensuring compliance with regulatory requirements and industry best practices.
This role involves developing and maintaining relationships with regulatory agencies and industry associations to ensure awareness of changes in regulatory requirements and industry best practices. The Quality Assurance Lead will also conduct internal quality audits and prepare internal audit reports where applicable.
Key Responsibilities:
* Design and implement a Quality Assurance framework to support laboratory work activities across Production and QC teams.
* Establish and maintain quality policies, procedures, and documentation, ensuring compliance with regulatory requirements and industry best practices.
* Develop and maintain relationships with regulatory agencies and industry associations to ensure awareness of changes in regulatory requirements and industry best practices.
* Conduct internal quality audits and prepare internal audit reports where applicable.
* Proactively identify quality metrics to drive continuous improvement for various laboratory processes.
Requirements:
* A degree and relevant experience in Biochemistry, synthetic chemistry, structural biology, or a similar discipline.
* At least 3 years' experience in a quality assurance role in the pharmaceutical or biotech industry, with experience in the development and implementation of quality systems.
* Strong laboratory and technical skills with awareness of laboratory OHS and risk management issues in a range of settings.
* Strong attention to details and organisational and project management skills, with the ability to manage multiple projects and priorities simultaneously.
* Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams in fast-paced and dynamic environments.
About Us:
Brunel is partnering with an Australian contract development and manufacturing operation specialising in nucleic acid products.