Q-ARM Analyst

NBISA Recruitment; Durban; On-site; ZAR 180,000 - 260,000; Full time

Job summary

National Bioproducts Institute NPC (NBI) invites applications for the QARM Analyst role. The successful candidate will facilitate the release of compliant plasma by sampling, testing, and reporting results to Manufacturing, ensuring traceability and adherence to procedures.

Responsibilities include executing artificial mini-pool and hyperimmune testing, serology for viral markers, ELISA QC, and proper sample handling. The role requires GMP/GLP understanding and computer literacy.

Qualifications

• Relevant science degree or diploma.
• At least one year laboratory experience.
• Must be computer literate i.e. MS Office.
• A good understanding of GMP/GLP.

Responsibilities

• Perform plasma sampling and reporting of results to facilitate release to Manufacturing.
• Test and manage Artificial mini-pool testing according to SOPs.
• Conduct hyperimmune testing and serology for viral markers (HIV1/2, HBsAg, anti-HCV).
• Perform ELISA quality control and ensure standards/controls ranges.
• Enter results into LIMS and ensure independent review prior to approval.

Skills

Laboratory experience

GMP/GLP knowledge

Computer literacy

Education

Science degree or diploma

Tools

MS Office

Job description

Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI’s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.

National Bioproducts Institute NPC has a vacancy for the role of QARM Analyst. The successful incumbent will be required to:

To facilitate the release of compliant plasma to Manufacturing by performing plasma sampling; testing and reporting of results.

Applications are invited from suitably qualified and experienced candidates.

• Relevant Science degree or diploma
• At least one year laboratory experience
• Must be computer literate i.e. MS office
• A good understanding of GMP/GLP

Duties & Responsibilities

Testing and Sample Management

Artificial mini-pool testing

• Ensure that Artificial mini pool (APT) testing is performed according to documented procedures
• Ensure that samples are labelled correctly and stored appropriately
• Prevent sample contamination by following validated cleaning procedures
• Perform dispensing of samples by use of the Tecan Robotic sampler ensuring awareness of sample traceability
• Ensure samples are labelled and packaged accordingly and sent timeously to external laboratories for testing

Hyperimmune testing

• Ensure samples are tested for hyperimmune titres in accordance to documented procedures
• Perform quantitation on hyperimmune samples as per documented procedures
• Ensure samples are labelled and stored appropriately

Viral Marker (serology testing)

• Perform relevant required tests in accordance to documented procedures for viral markers HIV1 and 2, HBsAg and anti-HCV on plasma, intermediate and final products.

ELISA

• Ensure that ELISA kits are quality controlled timeously as per documented procedures
• Ensure that standards and controls have an established range as per documented procedures

Results and Result entry

Evaluate all results

• Ensure that results are compliant relative to the standards and controls
• Ensure results and entered on LIMS timeously and are independently reviewed prior to approval of results

Sample Management and Archiving

• Ensure that samples are archived accordingly as per Standard Operating Procedures and ensure that all logbooks are signed and dated for acknowledgement

Document management

• All SOP’s PCDS are to be read and understood
• Ensure that all approved logbooks are filled in correctly and acknowledged by date and signature
• Ensure SOP’s are updated with required changes and implemented on SAP

Instrument maintenance

Instrument maintenance and calibration

• Perform regular maintenance as per required frequency documented for instruments
• Report any faults to the Head of Microbiological Sciences
• Ensure that instruments are calibrated before use and service providers required for maintenance are called out timeously

Laboratory maintenance

Laboratory Maintenance and Good House Keeping

• Ensure that all work surfaces are cleaned abiding by correct frequency with the appropriate disinfectants as per procedure
• Ensure that the laboratory areas are tidy at all times
• Ensure that documentation (results, log sheets etc.) are filed accordingly in designated files in the laboratory
• Ensure that temperature monitoring probes (Beyond Wireless) maintain temperature during working hours

Plasma Approval and discards and Lookbacks

Plasma approval:

• Ensure that compliant plasma boxes are approved and viral positive boxes are identified and labelled as non-compliant

Discards:

• Ensure that non-compliant boxes are discarded as per documented procedures
• Ensure that donation exceptions (Plasma Stores and Manufacturing) are discarded appropriately as per documented procedure

Lookbacks:

Ensure Lookback donations are returned to the supplier

SHE and Material Management

• Keep sufficient stock of materials required to perform required duties.
• Ensure SHE is followed at all times

Communication/Team work

Plasma Stores, Biotech and External Laboratories

• Liaise with the above participants or service providers related to any discrepancies and outstanding results