19 Aug
|
ParagonCare
|
Mount Waverley
19 Aug
ParagonCare
Mount Waverley
Quality Control Analyst
Immulab | Paragon Care Group
GMP Manufacturing | Mount Waverley The Opportunity
Immulab, part of the Paragon Care Group, is a leading Australian manufacturer and distributor of in-vitro diagnostics and equipment supporting blood banks, pathology and transplant laboratories across Australia and international markets.
We are seeking a Quality Control Analyst to join our team on a 12-month fixed-term maternity leave contract.
Reporting to the Quality Control Manager, you will play an important role in ensuring the quality, safety and compliance of products manufactured within our TGA-regulated GMP facility.
This is a hands-on laboratory position ideally suited to someone with experience in microbiology, haematology, medical laboratory science or a related discipline who enjoys working in a quality-focused and highly regulated environment.
You will undertake a broad range of QC activities including microbiological and haematology testing, immunohaematology testing, environmental monitoring, validation support and review of laboratory data.
Key Responsibilities
As a Quality Control Analyst, you will:
- Perform QC testing of raw materials, in-process samples and finished products in accordance with GMP requirements, approved procedures and regulatory standards.
- Conduct microbiological testing, environmental monitoring and related quality assessments.
- Perform haematology and immunohaematology testing, including red blood cell phenotyping, antibody screening, cell counts and serological assays.
- Accurately complete and review laboratory records while maintaining high standards of data integrity and Good Documentation Practice.
- Support method validation, equipment qualification, calibration and troubleshooting activities.
- Assist with laboratory investigations, deviations, CAPAs and continuous improvement initiatives.
- Maintain laboratory equipment,
materials and testing areas in accordance with required standards.
- Work collaboratively with Quality, Manufacturing and other operational teams to support product quality and timely release.
- Maintain a strong focus on laboratory safety, GMP compliance and inspection readiness.
About You
You are a detail-oriented laboratory qualified who takes pride in producing accurate, reliable work.
You will be comfortable working within established procedures and quality systems while also bringing a practical and collaborative approach to problem solving.
Essential Requirements
- Degree in Medical Laboratory Science, Biomedical Science, Microbiology, Haematology or a related scientific discipline.
- Practical laboratory experience in microbiology and/or haematology.
- Experience working within a GMP, ISO 15189, TGA-regulated or similarly controlled laboratory environment.
- Strong understanding of laboratory documentation and data integrity requirements.
- Excellent attention to detail and analytical and problem-solving skills.
- Ability to work effectively both independently and as part of a multidisciplinary team.
Highly Regarded
- Experience within IVD manufacturing, immunohaematology, transfusion science, reagent red blood cell testing or blood bank laboratories.
- Experience with microbiological testing and environmental monitoring programs.
- Familiarity with cleanroom operations and aseptic techniques.
- Previous experience working within a GMP manufacturing environment.
What’s in it for You?
This is an opportunity to join an established Australian manufacturer at an exciting time of growth and expansion.
You will
- Work in a modern, state-of-the-art GMP manufacturing and laboratory facility.
- Gain exposure to a broad range of QC activities across microbiology, haematology and immunohaematology.
- Work alongside experienced Quality, Manufacturing and technical professionals.
- Contribute to the manufacture of critical diagnostic products used to support blood testing and patient care.
- Be part of an Australian manufacturing business with a growing presence across international markets.
- Access opportunities for professional development within the broader Paragon Care Group.
About Immulab
Immulab, part of Paragon Care, specialises in the manufacture and distribution of in-vitro diagnostic products and equipment used by blood banks, pathology and transplant laboratories.
Our Australian manufacturing operations produce critical diagnostic products used in blood testing, supporting healthcare providers across Australia and increasingly throughout international markets.
Paragon Care is an ASX-listed healthcare company supplying and servicing medical equipment, devices and consumables across the healthcare sector.
If you are looking for an opportunity to apply your laboratory experience within a growing GMP manufacturing environment, we would love to hear from you.
Please note: Only successful candidates will be contacted.
Successful applicants will be required to complete pre-employment screening, including a medical assessment, drug and alcohol testing and a criminal history check, prior to commencement.
Applicants must have appropriate working rights in Australia. Paragon Care values diversity and encourages applications from people with disability, Aboriginal and Torres Strait Islander peoples and people from culturally and linguistically diverse backgrounds.
📌 Quality Control Analyst (Mount Waverley)
🏢 ParagonCare
📍 Mount Waverley