Quality Assurance Associate / Senior Associate

Quality Assurance Associate  / Senior Quality Assurance Associate

• Competitive remuneration package plus superannuation
• Social events 
• Career development opportunities 
• Full time Position  

About the company

This diversified business is a successful TGA/GMP licensed Pharmaceuticals Company that is well cemented in the Australian and Global markets. The business compounds and dispenses the latest imaging and therapy agents from manufacturers worldwide for use in Radiopharmacies, Oncology, PET Imaging and Medical Imaging Centres and also provides specialist manufacturing services.

Culture

You will be working with a collaborative team of professionals based at the Belconnen Office. The business has an inviting, open communication mindset and fosters an atmosphere of new ideas, innovation and continuous improvement.

Your new role

Reporting to the Quality Assurance Manager you will be working in the Radpharm Scientific Quality Department.

What you will get in return

• A family work environment 
• Career development opportunities
• Flexibility /Work life balance
• Supportive senior and executive management 
• Team building activities/social events

Duties

1. Prepare and/or review quality system documentation including SOP’s, specifications, batch manufacturing records, periodic product review reports etc.
2. Collate and analyse quality system information and data for effective trending purposes
3. Facilitate the operation of site QMS systems by Issuing system report numbers, Completion system effectiveness reviews, Supporting and/or leading quality meetings including change control and deviation
4. Assist with batch release
5. Assist with the auditing program
6. Maintain a working knowledge of GMP standards, requirements and amendments
7. Maintain a working knowledge of Radpharm Scientific final products and contract manufactured products.
8. Responsible for keeping personal training folder up to date
9. Support and drive a continuous improvement culture
10. Act as a delegate for the QA Manager when required
11. Complete and maintain training as per the position specific training syllabus for Quality Assurance Associate.

What you will need to succeed

• Highly organised
• Able to engage and communicate effectively with a range of stakeholders
• 2+ years’ experience as a Quality Associate within the health care industry 
• Attention to detail
• High proficiency in writing procedural and technical documents
• Bachelor’s degree in Science
• Sterile manufacturing/testing experience
• TGA/GMP regulatory knowledge