QC Specialist

A manufacturer and supplier of therapeutic proteins and diagnostic products is seeking a QC Specialist to join their team in Pinetown.

The QC Specialist will ensure excellence in the Quality Control departmental operations by leading technical initiatives and maintaining compliance with industry standards through:

• Identifying, developing, and validating new analytical methods relevant to the company's product range
• Qualification of QC laboratory equipment
• Investigating QC incidents and out-of-specification results
• Monitoring performance of inhouse controls and reference standards, and applying statistical quality controls to identify adverse trends
• Providing Laboratory Information Management System (LIMS) support
• Identifying and driving continuous improvement initiatives that align with cGMP requirements, regulatory standards, and industry best practice.

• Bachelor's science degree in Biochemistry, Chemistry, Analytical Chemistry, or a related field.
• MSc or PhD would be advantageous.
• Minimum 5 years’ analytical laboratory experience, of which 3 years has been in a laboratory supervisory position.
• Minimum 3 years' method or equipment validation experience.
• An understanding of GLP / cGMP.
• Project management experience.
• Experience using software such as LIMS, SAP, and Minitab would be advantageous.

* Only candidates that meet all the requirements should apply

** Only candidates that are shortlisted will be contacted

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