Quality Control PNS Analyst
About The Position
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.
Requirements
- Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field).
- 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 Parkville and Tullamarine.
- Ability to work on your own
Nice To Haves
- Previous experience working with animals is desirable.
Responsibilities
- 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.
Benefits
- CSL supports your well-being
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
