QC Support Analyst
- Support Quality Control operations to ensure testing activities are prepared and executed in accordance with cGMP requirements.
- Manage the receipt, storage, tracking, and distribution of laboratory samples.
- Assist with investigations relating to Out of Specification (OOS) results and maintain laboratory documentation.
At CSL Seqirus, we are committed to protecting public health through the development and manufacture of influenza vaccines and other innovative solutions. As a global leader in influenza prevention, we are dedicated to quality, continuous improvement, and excellence in manufacturing and laboratory operations.
The Opportunity
We are seeking a highly motivated QC Support Analyst to join our Quality Control Support team based across our Tullamarine and Broadmeadows sites. This role plays a critical part in supporting laboratory operations and ensuring Quality Control activities are performed in accordance with current Good Manufacturing Practice (cGMP) requirements. The role supports the release and testing of products through effective sample management, laboratory support activities, environmental monitoring, stability programs, and quality systems management.
This is a permanent, full-time position based onsite at our Tullamarine facility. Standard business hours apply; however, as our operations run seven days a week, flexibility is required to participate in a rotating roster from Monday to Sunday, with occasional overtime as needed to support business requirements.
Reporting to the QC Support Team Leader, you will:
- Support Quality Control operations to ensure testing activities are prepared and executed in accordance with cGMP requirements.
- Support environmental monitoring and utility sampling activities, including water systems, compressed air systems, and manufacturing environments.
- Manage the receipt, storage, tracking, and distribution of laboratory samples.
- Perform data entry and maintenance activities within Laboratory Information Management Systems (LIMS) and SAP.
- Assist with the creation, maintenance, and administration of stability and retention programs.
- Coordinate sample logistics with approved contract testing laboratories.
- Assist with investigations relating to Out of Specification (OOS) results, invalid assays, and unusual laboratory findings.
- Conduct consumable stocktake, verify equipment calibration status, and arrange calibrations with external vendors where necessary.
- Maintain laboratory documentation, records, and procedures in compliance with regulatory expectations.
- Support validation, maintenance, and continuous improvement initiatives across QC operations.
- Ensure the laboratory remains inspection and audit-ready while promoting a safe working environment.
- Represent Quality Control at cross-functional meetings and provide excellent customer service to internal stakeholders.
About You
To be successful in this role, you will bring:
- Degree qualification in Science, Microbiology, Biotechnology, Chemistry, Pharmaceutical Sciences, or a related discipline.
- Experience working within a GMP-regulated pharmaceutical, biotechnology, vaccine, or healthcare manufacturing environment.
- Strong understanding of Quality Control laboratory operations, sample logistics, aseptic sampling and quality systems.
- Experience using LIMS or similar laboratory information management systems.
- Excellent attention to detail and documentation practices.
- Strong problem-solving and investigation skills.
- Effective communication and stakeholder management abilities.
- Ability to prioritise tasks and work collaboratively within a team environment.
- Commitment to quality, compliance, and continuous improvement.
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