GMP QC Support Analyst — Lab Ops & Data Integrity

CSL; Melbourne; On-site; AUD 65,000 - 90,000; Full time

Job summary

CSL Seqirus is seeking a highly motivated QC Support Analyst to join the Quality Control Support team across Tullamarine and Broadmeadows sites. The role supports the release and testing of products, sample management, environmental monitoring, stability programs and quality systems management.

This is a permanent, full-time position based onsite at our Tullamarine facility with a rotating Monday-Sunday roster and occasional overtime to meet business needs.

Qualifications

• Degree in Science, Microbiology, Biotechnology, Chemistry, Pharmaceutical Sciences or related discipline.
• Experience in a GMP-regulated pharmaceutical/biotech/vaccine/healthcare manufacturing environment.
• Strong understanding of QC laboratory operations, sample logistics, aseptic sampling and quality systems.
• Experience using LIMS or similar laboratory information management systems.

Responsibilities

• Support Quality Control operations to ensure testing activities are performed per cGMP requirements.
• Support environmental monitoring and utility sampling activities (water, compressed air, manufacturing environments).
• Manage receipt, storage, tracking, and distribution of laboratory samples.
• Perform data entry and maintenance in LIMS and SAP.
• Assist with stability and retention program development and maintenance.
• Coordinate sample logistics with approved contract testing laboratories.
• Assist with investigations related to OOS results, invalid assays, and unusual findings.
• Conduct consumable stocktakes, verify equipment calibration, arrange calibrations with vendors.
• Maintain laboratory documentation, records and procedures in regulatory compliance.
• Support validation, maintenance and continuous improvement initiatives across QC operations.
• Ensure the laboratory remains inspection-ready and safe for staff.

Skills

Attention to detail

Problem solving

Communication

Teamwork

Stakeholder management

Education

Science degree in Science / Microbiology / Biotechnology / Chemistry / Pharmaceutical Sciences

Related discipline

Tools

LIMS

SAP

Job description

CSL Seqirus is seeking a highly motivated QC Support Analyst to join the Quality Control Support team across Tullamarine and Broadmeadows sites. The role supports the release and testing of products, sample management, environmental monitoring, stability programs and quality systems management.

This is a permanent, full-time position based onsite at our Tullamarine facility with a rotating Monday-Sunday roster and occasional overtime to meet business needs.