Introduction
Based in Pinetown, KwaZulu-Natal, our client is a premier, highly specialized biopharmaceutical manufacturer dedicated to producing life-saving protein therapies, immunoglobulins, and diagnostic products derived from biological raw materials. Guided by a mission to alleviate patient suffering and improve overall quality of life, the organization operates a world-class, cGMP-compliant production facility that serves critical healthcare needs across South Africa and the broader continent.
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
Profile
The ideal candidate is a detail-oriented Laboratory Analyst with a solid scientific background in microbiology, biochemistry, or biotechnology. They possess at least 1 year of practical laboratory experience within a cGMP/GLP-compliant environment, ideally within biologicals, pharmaceuticals or clinical diagnostics. They are skilled in serology testing, handling automated lab liquid systems, entering data accurately into LIMS, and ensuring that raw biological materials meet strict quality and safety standards before release into manufacturing.
We offer
Impactful Work: Join a premier biopharmaceutical manufacturer operating a state-of-the-art facility, producing vital biological therapies and diagnostics that directly improve patient quality of life.
Professional Growth: Gain hands-on exposure to advanced laboratory automation (Tecan robotic systems), cGMP/cGLP standards, LIMS, and SAP within a highly regulated life sciences environment.
Competitive Package: A market-related remuneration package aligned with biopharmaceutical industry standards, supported by comprehensive health and occupational medical oversight.
Collaborative Environment: Work alongside a skilled, dedicated technical team in a structured environment that values quality orientation, team communication, and personal leadership.
