QC Analyst

CSL Vifor; Shire of Macedon Ranges; On-site; AUD 65,000 - 100,000; Full time

Job summary

CSL Vifor 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 testing of product in accordance with GMP requirements and company quality standards.

The position involves day, afternoon and night rotational shifts including weekends, and requires collaboration across the QC group. You will also use LIMS for data entry and help maintain calibration and quality systems.

Qualifications

• Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field).
• Experience with animals is desirable.
• Experience in a Quality Control environment and GMP knowledge.
• Proficiency in laboratory techniques including assay preparation and execution.
• Experience with LIMS for data entry and management.
• Able to work rotational day, afternoon and night shifts, including weekends.
• First 12 months may require working from other locations including Tullamarine.
• Ability to work independently.

Responsibilities

• Support the team to ensure biological and non-biological assays are prepared and executed in accordance with cGMP.
• Assist in the review, update, and issue of documentation.
• Assist with investigations of OOS test results or unusual data.
• Ensure testing is conducted per approved procedures and materials are stored/labelled.
• Enter data in LIMS and maintain calibration/cleaning records.
• Proactively support operations to prevent invalid assays and reduce OOS results.
• Support validation and maintenance systems to ensure plant/equipment availability.
• Identify and implement quality improvements within each area.

Skills

Laboratory techniques

Documentation

Independent worker

Adaptability to shift work

Education

Bachelor's degree in Biology/Chemistry/Biochemistry or related field

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/productsare 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 degreein 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)regulationsand 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