Qc Specialist

Scistaff; Durban; On-site; ZAR 420,000 - 660,000; Full time

Job summary

Scistaff partners with a Durban-based manufacturer and supplier of therapeutic proteins and diagnostic products to recruit a QC Specialist in Pinetown.

The role focuses on leading QC initiatives, method and equipment validation, investigating deviations, and supporting LIMS, SAP and Minitab while ensuring cGMP compliance.

Qualifications

• Degree in Biochemistry, Chemistry, Analytical Chemistry or related field.
• Minimum 5 years' analytical lab experience, including 3 years in supervision.
• Minimum 3 years' method or equipment validation experience.
• Understanding of GLP and cGMP.
• Experience with LIMS, SAP and Minitab is advantageous.

Responsibilities

• Identify, develop, and validate new analytical methods relevant to product range.
• Qualification of QC laboratory equipment.
• Investigate QC incidents and out-of-specification results.
• Monitor performance of in-house controls and reference standards with statistical QC.
• Provide LIMS support and drive continuous improvement to meet regulatory standards.

Skills

Quality control

Supervisory experience

Analytical thinking

Statistical quality control

Education

Bachelor's degree in Biochemistry / Chemistry / Analytical Chemistry

MSc or PhD (advantageous)

Tools

LIMS

SAP

Minitab

Job description

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.

Key Requirements

• 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.
• Experience using software such as LIMS, SAP, and Minitab would be advantageous.