QC Analyst

CSL; Woodend; On-site; AUD 60,000 - 80,000; Full time

Job summary

CSL is seeking a Laboratory Analyst for the Woodend site in a full-time, permanent role within the Quality Control, PNS team. The role involves supporting GMP-compliant testing, documenting results, and investigating OOS data.

You will work day, afternoon and night shifts, including weekends, and may be based at other sites during the first year (e.g., Tullamarine). The ideal candidate holds a relevant science degree, has experience with GMP, LIMS, and laboratory techniques, and can work

Qualifications

• Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field).
• Experience in a Quality Control environment and strong knowledge of GMP regulations/guidelines.
• Proficiency in assay preparation and execution; familiarity with laboratory techniques.

Responsibilities

• Support QC testing to GxP standards and ensure procedures are followed.
• Assist in review/update of documentation and investigations of OOS results as required.
• Maintain data integrity in LIMS and manage equipment calibration and cleaning.
• Assist with validations and maintenance of systems to ensure plant and process readiness.
• Identify and implement improvements to enhance quality across the QC area.

Skills

GMP knowledge

Laboratory techniques

Animal handling

Shift flexibility

Self-motivation

Education

Bachelor's degree in a scientific discipline

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