QARM ANALYST

Introduction

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

Duties & Responsibilities

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

Desired Experience & Qualification

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

Package & Remuneration

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