QC Analyst

CSL; Woodend; On-site; AUD 70,000 - 90,000; Full time

Job summary

CSL is seeking a Laboratory Analyst to join the Quality Control, PNS team at the Woodend site on a full-time permanent basis. The role supports QC testing under cGMP guidelines and involves day, afternoon, and night rotations including weekends.

You will perform assay preparation, data entry in LIMS, documentation reviews, and contribute to investigations of out-of-spec results, with a focus on maintaining calibration and lab readiness across shifts.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• Experience with GMP regulations and guidelines.
• Proficiency with assay preparation and execution.

Responsibilities

• Support QC testing to ensure compliance with cGMP.
• Review, update and issue documentation.
• Investigate Out-of-Specification (OOS) results as required.
• Ensure testing follows approved procedures and proper labeling.
• Use LIMS for data entry and maintain equipment calibration.
• Support improvements to quality within each area.
• Work across day, afternoon and night shifts including weekends.

Skills

GMP compliance

Laboratory techniques

Documentation review

Independent worker

Education

Bachelor's degree in Biology/C Chemistry/ Biochemistry

Tools

LIMS

Job description

We are looking for a Laboratory Analyst to join our Quality Control, Products of National Significance (PNS) team on a full time, permanent basis at our Woodend site. You will support the teams within the Quality Control (QC) Group to enable testing of product in accordance with the code of Good Manufacturing Practice (GMP).

This is a permanent opportunity based at our Woodend site and will require to work day, afternoon and night rotational shifts including weekends.

Reporting To The QC Team Leader, You Will

• Support the team to ensure that the biological and non-biological assays performed in each department are prepared and executed in accordance with the code of Good Manufacturing Practice (cGMP)
• Assist in the review, update, and issue of documentation.
• Assist with investigations of Out-of-Specification (OOS) test results, invalid assays or when unusual data is observed as required.
• Ensure testing is conducted in accordance with the approved procedures. Ensures containers/materials/samples/products are stored and labelled according to specifications completing all necessary documentation.
• Use LIMS for data entry of quality control testing results and maintaining laboratory equipment calibration and cleaning.
• Support the operational area pro-actively to prevent invalid assays and reduce out of specification results.
• Support the validation and maintenance systems of an operational area to ensure plant, equipment and processes is available as required.
• Actively seek, recommend, and implement improvements to enhance quality within each functional area.

Experience

• Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field).
• Previous experience working with animals is desirable.
• Previous experience in a similar Quality Control environment and strong knowledge on Good Manufacturing Practice (GMP) regulations and guidelines.
• Proficiency in laboratory techniques including assay preparation and execution.
• Experience with Laboratory Information Management Systems (LIMS) for data entry and management.
• Flexible to work on rotational shifts including day, afternoon and night shift work and weekends.
• During the first 12 months, working from other locations as required, including Tullamarine.
• Ability to work on your own