Quality Control PNS Analyst
We are seeking a Quality Control (QC) PNS Analyst to join our Quality Control, Products of National Significance (PNS) team at our Woodend site.
This is a permanent opportunity based at our Woodend site and will require working in day, afternoon, and night rotational shifts.
The successful candidate will support the teams within the Quality Control (QC) Group to enable testing of product in accordance with the code of Good Manufacturing Practice (cGMP).
Responsibilities:
* Ensure that biological and non-biological assays performed in each department are prepared and executed in accordance with cGMP regulations.
* Review, update, and issue documentation as required.
* Investigate Out-of-Specification (OOS) test results, invalid assays, or unusual data.
* Ensure testing is conducted in accordance with approved procedures.
* Use Laboratory Information Management Systems (LIMS) for data entry and equipment calibration.
* Support operational areas proactively to prevent invalid assays and reduce out of specification results.
* Validate and maintain systems to ensure plant, equipment, and processes are available as required.
* Implement improvements to enhance quality within functional areas.
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 knowledge of GMP regulations.
* Proficiency in laboratory techniques including assay preparation and execution.
* Experience with LIMS for data entry and management.
* Flexible to work on rotational shifts including day, afternoon, and night shift work.
About Us:
CSL Limited is a global biotechnology leader in the development, manufacturing, and commercialization of biotherapies and vaccines. Our products save lives and protect people from some of the world's most devastating diseases.
Benefits:
CSL offers a comprehensive benefits package, which includes medical, dental, and vision coverage, 401(k), stock options, and more.