QARM Analyst

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

JOB OPPORTUNITY: QARM ANALYST

Location: Pinetown, KwaZulu-Natal

Position Type: Full-time

Industry: Biotechnology / Biopharmaceuticals

About the Company

Our client is a leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products. Guided by a commitment to improving patients' quality of life and alleviating pain and suffering, the organization operates a state-of-the-art biopharmaceutical manufacturing facility in Pinetown dedicated to producing lifesaving biological products derived from human plasma.

Role Overview

The QARM (Quality Assurance & Regulatory Affairs / Microbiology) Analyst plays a vital role in ensuring the safety, compliance, and quality of biological raw materials and finished products. The primary focus of this role is to conduct viral marker testing, serology assays, and sample management to facilitate the safe release of compliant plasma to manufacturing operations.

Key Responsibilities & Expectations

• Testing & Sample Management:

  • Perform viral marker serology testing (HIV-1 and 2, HBsAg, anti-HCV) on plasma, intermediate materials, and final products in accordance with validated procedures.

  • Conduct ELISA assays, including quality control of test kits, standards, and controls.

  • Perform artificial mini-pool testing (APT) and sample dispensing using automated Tecan Robotic samplers.

  • Package and send samples for external hyperimmune testing and perform quantitation assays as required.

• Data Management & Plasma Approval:

  • Evaluate test results against established controls and enter data timeously into the LIMS system for independent review.

  • Formally approve compliant plasma batches for manufacturing.

  • Identify non-compliant/viral-positive donations, manage safe discards, and execute supplier lookback procedures.

  • Maintain accurate laboratory logbooks, archive retain samples, and update SOPs on SAP.

• Laboratory & Instrument Maintenance:

  • Perform routine maintenance, cleaning, and calibration of laboratory equipment.

  • Monitor laboratory ambient and controlled storage temperatures continuously.

  • Maintain clean, sanitized work areas and adhere strictly to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.

• Safety, Health, & Environment (SHE):

  • Comply with site SHE rules, OSH Act regulations, and mandatory training requirements for handling hazardous and biologically active chemicals.

  • Maintain appropriate stock levels of laboratory materials and reagents.

Minimum Requirements

• Education: A relevant Tertiary Science Degree or National Diploma (e.g., Microbiology, Biochemistry, Biotechnology, Medical Bioscience, or Analytical Chemistry).

• Experience: Minimum of 1 year of hands-on laboratory experience.

• Technical Skills: Sound knowledge of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).

• Computer Literacy: Proficiency in MS Office Suite and experience with laboratory software systems (e.g., LIMS, SAP, automated liquid handlers) is highly advantageous.

• Medical Fitness: Pre-employment, routine, and exit medical assessments are compulsory due to the nature of biopharmaceutical manufacturing.

Core Competencies

• Exceptional attention to detail and analytical skills

• Quality orientation and awareness

• Strong planning, organizing, and follow-up capabilities

• Excellent interpersonal and communication skills for multi-departmental teamwork

• Personal leadership and proactive problem-solving