Overview
Quality Assurance Associate Jobs in Sydney, New South Wales, Australia at Genea Biomedx
Title: Quality Assurance Associate
Company: Genea Biomedx
Location: Sydney, New South Wales, Australia
Responsibilities:
QMS
•Support development, implementation and maintenance of the Genea Biomedx QMS.
• Review and maintenance of QMS records.
• Writing QMS documentation including standard operating procedures, work instructions, policies, related forms and templates.
• Document control.
• Administration of the training system.
• Assist with internal and external audits, ensure compliance with audit schedules.
• Assist with supplier review and approval programs.
• Investigation and execution of CAPA’s, Change Control, Change Requests and other associated tools.
• Review of environmental monitoring results.
• Release of inwards goods.
• Review and approval of batch documentation, logs, test results, C of A’s and related documents for batch release and shipment.
• QA sign-off for release of product to market.
• Support calibration, maintenance and validation activities.
• Ensure departmental compliance with standard operating procedures, work instructions and policies.
Manufactoring QA
• Batch record review, maintenance and storage.
WHS
• Operate within the scope of WHS requirements.
• Work with WHS representatives to integrate WHS with the QMS where feasible.
Qualifications：
Individual Competencies
• Microsoft Office suite (Word, Excel, Powerpoint).
• Excellent oral and written English with ability to communicate at all levels internally and externally.
• Initiative, accuracy and attention to detail.
• Excellent work ethic and organisational skills.
• Ability to participate as an active team member and work independently.
• Ability to adapt to a fast-pacing environment with frequent deadlines.
Required Experience
• Experience within a regulated, technical environment.
• Technical writing.
Required Qualifications
• Appropriate science qualifications (Bachelor’s degree in a scientific discipline)
