Quality Associate (Melbourne Or Brisbane Based Role)

We have an exciting opportunity for a Quality Associate to join our growing team! This role could be based in either Melbourne or Brisbane!

Nucleus Network is the only global phase 1 clinical trial specialist with facilities in the USA and Australia, fulfilling our purpose of “advancing medicine and improving lives”, by attracting the best talent.

Since our establishment in 2004, Nucleus Network has conducted well over 1000 phase 1 clinical trials for biotechnology and pharmaceutical companies from the USA, Europe, Australia, Japan, South Korea, Taiwan, and China.

We are defined by our values, great work culture, commitment to staff development and dedication to provide the best possible work environment.

Come and join us through this exciting journey of expansion and gain world-class experience servicing some of the most innovative biotechnology and pharmaceutical companies globally.

About the role

TheQuality Associate will be responsible for assisting in the management of quality systems and operations for the purpose of supporting trial realisation activities across Nucleus Network. This will include supporting the business operational principles of project management and risk management, assisting the day-to-day activities within quality operations, and driving continuous quality improvement.

Key responsibilities

• Facilitate documentation global integration initiatives
• Drive compliance with Learning & Development requirements
• Support new staff induction with onboarding and training sessions
• Assist in the management of Change Control 
• Support the business with equipment management, including for validation activities
• Prepare for, and assisting during, audits/inspections
• Aid Quality Event and CAPA Management and tracking
• Conduct internal audits to confirm compliance with regulatory requirements
• Aid the Clinical Study Teams with compliance of all quality system elements 
• Identify, facilitate, and assist with business improvement activities
• Facilitate policy, Standard Operating Procedures, forms and template development, cyclic reviews, and updates

Requirements

• Bachelor of Science in relevant quality/technical discipline, Bachelor of Nursing or equivalent to at least 2 year NR degree
• Minimum 1-2 years’ experience in Quality, or related medical clinical/Pharma industry field
• Practical knowledge and experience in GXP Quality Systems
• Demonstrated high level of accuracy and attention to detail
• Strong communication, prioritisation, and organisational skills
• Demonstrated experience working under pressure while managing competing demands
• Ability to competently utilise and self-train in computerised systems including, but not limited to MS Word, Visio, Excel, SharePoint, and Adobe Acrobat

Desirable

• Sound practical knowledge of global Good Clinical Practice (GCP) requirements
• Experience with Quality System Documentation and Good Documentation Practices
• Knowledge of ISO9000 quality system model
• Demonstrated ability to work accurately, follow instructions/schedules/timelines
• Previous experience in the Pharmaceutical / Life Science TGA/FDA regulated industry
• Experience in transformation and integration of Quality Systems
• Experience with conducting audits, deviation management and equipment management

Benefits

• Meaningful Impact - 'advancing medicine, improving lives' of people around the world
• Professional Growth Opportunities - We believe in investing in our employees' development
• Employee Recognition - Your hard work and achievements will be recognised and rewarded
• Employee Wellness Initiatives - We prioritize the health and wellbeing of our employee 

If you are interested in applying for this position, please include a CV and cover letter with your application.  

At Nucleus Network we are committed to creating a supportive and inclusive space where every individual feels they can be their full selves.  Our policy applies to all aspects of employment, including our hiring and selection process.  We are an equal opportunities employer; seeking people from all life stages, backgrounds and life perspectives. Our focus are people who embody our values of drive, teamwork, customer focus and excellence.

For further information about Nucleus Network, please go to www.nucleusnetwork.com.au