QARM ANALYST at Vela Personnel · Hlabisa

Purpose:

A Pharmaceutical company is seeking a suitably qualified and experienced QARM Analyst to facilitate the release of compliant plasma to manufacturing by performing plasma sampling, testing, and reporting of results

Key Job Outputs:

Testing and Sample Management

• Perform artificial mini-pool testing according to documented procedures
• Ensure samples are labelled correctly and stored appropriately
• Prevent sample contamination by following validated cleaning procedures
• Dispense samples using the Tecan Robotic sampler while ensuring sample traceability
• Ensure samples are labelled, packaged, and sent timeously for external Hyperimmune testing
• Ensure samples are tested for hyperimmune titres in accordance with documented procedures
• Perform quantitation on hyperimmune samples as per documented procedures
• Perform viral marker serology testing for HIV1 and 2, HBsAg, and anti-HCV on plasma, intermediate, and final products

ELISA

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

Results and Result Entry

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

Sample Management and Archiving

• Ensure samples are archived according to Standard Operating Procedures
• Ensure all logbooks are signed and dated for acknowledgement

Document Management

• Read and understand all SOPs and PCDS
• Ensure approved logbooks are completed correctly and acknowledged by date and signature
• Ensure SOPs are updated with required changes and implemented on SAP

Instrument Maintenance

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

Laboratory Maintenance and Good Housekeeping

• Ensure all work surfaces are cleaned according to the correct frequency using the appropriate disinfectants as per procedure
• Ensure laboratory areas are tidy at all times
• Ensure documentation, including results and log sheets, is filed accordingly in designated laboratory files
• Ensure temperature monitoring probes maintain temperature during working hours

Plasma Approval, Discards, and Lookbacks

• Ensure compliant plasma boxes are approved
• Identify and label viral positive boxes as non-compliant
• Ensure non-compliant boxes are discarded according to documented procedures
• Ensure donation exceptions from Plasma Stores and Manufacturing are discarded appropriately
• Ensure lookback donations are returned to the supplier

SHE and Material Management

• Maintain sufficient stock of materials required to perform duties
• Ensure SHE requirements are followed at all times

Communication and Teamwork

• Liaise with Plasma Stores, Biotech, and external laboratories
• Communicate with participants and service providers regarding discrepancies and outstanding results

Core Competencies:

• Personal leadership
• Leading and influencing others
• Business impact
• Managing relationships
• Planning and organising
• Follow-up and teamwork
• Attention to detail and analysis
• Quality awareness
• Computer literacy
• Quality orientation
• Good communication and interpersonal skills
• Good Laboratory Practice
• Good Manufacturing Practice

Qualifications:

• Relevant Science degree or diploma

Experience:

• At least one year of laboratory experience
• Computer literacy, including MS Office
• Good understanding of GMP and GLP

Salary: Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013