QA & Regulatory Microbiology Analyst – Plasma Biotech

Pronel Personnel; Pinetown; On-site; ZAR 420,000 - 650,000; Full time

Job summary

Pronel Personnel is seeking a QARM Analyst in Pinetown, KwaZulu-Natal for a full-time role. The incumbent will perform viral marker serology testing, ELISA assays, and sample management to facilitate safe plasma release to manufacturing operations.

The role requires a relevant science degree, 1 year of laboratory experience, and strong GMP/GLP knowledge. Proficiency in LIMS/SAP and MS Office is advantageous; pre-employment medicals are mandatory.

Qualifications

• Education as stated: a relevant tertiary science degree or national diploma.
• Minimum 1 year hands-on laboratory experience in a GMP/GLP setting.
• GMP and GLP knowledge essential for compliant testing.
• Proficiency in MS Office and laboratory software (LIMS, SAP; automation is advantageous).
• Pre-employment medicals and ongoing health assessments required.

Responsibilities

• Perform viral marker serology testing on plasma and products per validated procedures.
• Conduct ELISA assays and QC of test kits, standards, and controls.
• Perform APT and sample dispensing using automated robotic samplers.
• Enter results into LIMS; approve compliant plasma batches for manufacturing.
• Maintain logs, retain samples, and update SOPs in SAP; ensure GLP and GMP standards.

Skills

Attention to detail

Analytical skills

Quality orientation

Planning & organizing

Interpersonal communication

Problem-solving

GMP

GLP

MS Office

LIMS SAP automation

Education

Tertiary Science Degree or National Diploma (Microbiology, Biochemistry, Biotechnology, Medical Bioscience, Analytical Chemistry)

Tools

LIMS

SAP

Automated liquid handlers

MS Office

Job description

Pronel Personnel is seeking a QARM Analyst in Pinetown, KwaZulu-Natal for a full-time role. The incumbent will perform viral marker serology testing, ELISA assays, and sample management to facilitate safe plasma release to manufacturing operations.

The role requires a relevant science degree, 1 year of laboratory experience, and strong GMP/GLP knowledge. Proficiency in LIMS/SAP and MS Office is advantageous; pre-employment medicals are mandatory.