Sterility Assurance Specialist

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Synergie Australia is seeking an Associate Sterility Assurance Specialist for a trusted client located in Broadmeadows.

The important parts:

• Pay: Competitive hourly rate Super Duration: 12-month contract
• Hours: Monday-Friday Standard business hours (approx. 8:00am-4:00pm) 38 hrs per week Hybrid arrangement (3 days onsite 2 days WFH)

What you will be required to do:

Youll play a key role within the Sterility Assurance team supporting the oversight and lifecycle management of sterility assurance monitoring controls at a leading pharmaceutical manufacturing site. This role combines technical microbiology expertise data trending quality oversight and stakeholder engagement.

• Supporting Environmental Monitoring (EM) and Personnel Monitoring programs across manufacturing facilities
• Reviewing and analysing viable and non-viable monitoring data and identifying emerging trends
• Supporting sterility assurance investigations deviations CAPAs and contamination control initiatives
• Assisting with validation and qualification activities for facilities utilities equipment personnel and microbiological methods
• Preparing and reviewing trend reports risk assessments SOPs protocols and quality documentation
• Providing quality oversight for sterility assurance systems and compliance activities
• Partnering closely with Operations Manufacturing Engineering Validation QA and QC teams
• Supporting continuous improvement initiatives and maintaining compliance with GMP and regulatory requirements

To be successful in the role you will:

• Bachelors degree in Microbiology Biology Biotechnology Pharmaceutical Science or a related scientific discipline
• 3-5 years experience within Sterility Assurance Environmental Monitoring QC Microbiology QA or a related pharmaceutical manufacturing role
• Experience working within GMP-regulated pharmaceutical manufacturing environments
• Strong understanding of Environmental Monitoring contamination control and sterility assurance principles
• Experience with data trending Excel reporting and investigation of trend increases or monitoring excursions
• Excellent communication and stakeholder management skills
• Strong problem-solving root cause analysis and investigation skills
• Experience supporting aseptic manufacturing environments will be highly regarded

Whats on offer for you:

• Opportunity to join a global leader in pharmaceutical manufacturing
• Exposure to key sterility assurance and contamination control programs
• Significant stakeholder engagement and site ownership opportunities
• Collaborative and supportive team environment
• Hybrid working arrangement available
• Potential for long-term career growth and development within the organisation

Synergie Australia delivers a full 360º recruitment solution consisting of temporary and permanent recruitment services and more. Safety is of the highest priority and Synergie Australia prides itself on fostering a culture that champions guidance and care in the workforce.

Beyond recruitment Synergie Australia is motivated to improve everyday standards within the working landscape so people can thrive today and in the future. This approach delivers real change to communities by improving workplaces local economies inequalities and changes to the climate. If you aspire for better lets work together.

If youre ready click apply now or contact our branch on.

Synergie Australia connects people with safe rewarding work across Australia. From temporary roles to permanent opportunities we support you at every stage of your career. Learn more and view current opportunities at .