Quality Control (QC) PNS Analyst

Job Description

The Opportunity:

We are looking for a Quality Control (QC) PNS Analyst to join our Quality Control, Products of National Significance (PNS) team 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 in day, afternoon and night rotational shifts.

Responsibilities:

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.
  

• 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.