Lead Qc Analyst

**Job Advert Summary**:
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 Lead QC Analyst. The successful incumbent will be required to:
To ensure effective and efficient day-to-day QC laboratory operations, focusing on the monitoring and co-ordination of QC sampling, testing, and reporting of results on raw materials, printed packaging materials, in-process samples and final products. Further, to ensure compliance to good laboratory practice, good manufacturing practice, health, safety and environmental requirements, as well as sound scientific principles, ultimately to assure the accuracy and integrity of analytical results and therefore the quality, safety and efficacy of products tested by the QC department. Lastly, to ensure effective management of the department’s internal quality control, external quality control and the stability programmes.

**Minimum Requirements**:

- Appropriate science degree e.g. BSc (Biochemistry, Chemistry or Analytical Chemistry)
- Masters degree preferred.
- 4 -5 years analytical laboratory experience.
- 1-2 years laboratory supervisory/management experience.
- Computer literacy MS Office (Word, Excel, Powerpoint and Outlook)
- Laboratory Information Management Systems (LIMS) experience.
- Understanding of GMP and good laboratory techniques

**Duties and Responsibilities**:
**Daily QC laboratory supervision**:

- Oversee QC Laboratory operations to ensure staff members perform required duties as per QC program, including management of the overtime schedule.
- Ensure all laboratory functions are carried out within the set timelines.
- Ensure the integrity of results is maintained by making necessary interventions to improve or correct current procedures and practices.
- Identify and resolve problems relating to staff, processes and equipment.
- Check, review and authorise results as per QC internal program.
- Manage the routine competency testing programs and training of laboratory staff on new analytical techniques.
- Manage the QC department chemical and consumables stores system, including monitoring of stock usage and wastage to enhance cost effectiveness.
- Manage the QC department reference sample system

**Internal quality control and external quality control programmes**:

- Ensure that the internal and external laboratory QC testing program is maintained.
- Coordinate and monitor the preparation of standards and inhouse controls, and release for routine use.
- Monitor test performance by performing statistical analysis on monthly reports on inhouse controls and reference standards, to identify trends.
- Coordinate the external testing schemes and evaluate the results/performance of assays.
- Generate and interpret IQC/EQC reports in line with the IQC/EQC program.
- Maintain the standards and inhouse controls in LIMS, using the LIMS SQC module.

**Stability programme**:

- Coordinate the overall stability program using LIMS and ensure control of stability studies.
- Prepare stability study protocols.
- Evaluate stability stage results and submit brief stage reports to the QC manager.

**Raw materials testing**
- Ensure sampling, testing and reporting of raw materials such as chemicals, water, printed and packaging components is performed as per QC program.
- Check documentation of incoming raw materials and resolve issues.
- Allocate raw materials to QC analysts for testing.
- Audit documentation of completed materials and sign off the reports.
- Authorise results of completed analysis in LIMS and SAP.

**Perform testing of starting, Intermediate and final products and other samples**
- Plan, organise and coordinate testing of incoming samples in accordance with the product specification, production requirements and dossier requirements.
- Track and monitor the progress of testing and reporting of results to ensure test results are available within set timelines.
- Ensure that analytical tests are performed according to the approved SOP’s.
- Process results in LIMS and/or SAP and monitor trends periodically as per schedule.
- Provide reports on test result trends using LIMS, on monthly and quarterly basis.
- Be multi-skilled in all aspects of laboratory testing.
- Provide technical expertise to internal customers.
- Support the QC Specialist in out-of-spec investigations and handling of product quality related complaints.

**Laboratory Maintenance**:

- Coordinate routine general laboratory maintenance to ensure the lab is clean and tidy at all times.
- Coordinate maintenance, routine service and calibration of lab equipment by in-house or via external contractors.
- Ensure that the glassware cleaning process is effective, and glassware is available and in good condition.

**Quality management**
- Ensu