QC Analyst - Pinetown at National Bioproducts Institute

Minimum Requirements

• Appropriate science diploma/degree e.g. N. Dip Analytical chemistry, BSc, Microbiology, Biomedical Technology
• 2 years analytical laboratory experience.
• Computer literacy MS Office ( Word, Excel, Power Point and Outlook)
• Understanding of GLP / GMP.

Duties & Responsibilities

Laboratory maintenance

• Perform routine maintenance of lab equipment (in-house or via external contractors).
• Perform routine general laboratory maintenance.
• Ensure the lab is clean and tidy at all times.
• Monitor the lab as per schedule
• Clean glassware immediately after use.
• Monitor departmental stock usage and wastage of test kits and reagents and laboratory consumables and take necessary action to enhance cost effectiveness.

Method development and validation

• Perform test and method validations according to internal QC program and perform validations on new equipment.
• Draw up user requirement specifications.
• Prepare validation protocols.
• Perform validations.
• Prepare validation report/s.
• Implement method/ equipment.
• Develop/optimise methods for approval by Head: QC.
• Monitor performance of assigned method/s.
• Generate and interpret IQC reports in line with IQC/EQC program.

Raw material testing

• Perform sampling, testing and reporting of raw materials such as chemicals, media, water, printed and packaging components by
• Following the appropriate procedures/practise.
• Receiving and retaining samples in the appropriate containers and correct locations/conditions.

Quality management

• Up-hold quality standards. Ensure GMP/GLP is followed at all times
• Ensure all tasks and functions are performed in compliance with GMP.
• Constantly ensuring the quality of final products by conducting stability studies.
• Ensure operational compliance by management of non-compliance through review of root cause analysis and implementation of required corrective action within agreed timeframes.
• Analyse systems non conformances and elevate problems and /or
• Monitor compliance to safety policies and procedures.
• Compile SOP’s for new equipment / methods.
• Continuously review existing SOP’s within the required timeframe.
• Monitors maintenance and calibration programmes for the laboratory.
• Ensure operational compliance by management of non-compliance through review of root cause analysis and implementation of required corrective action within agreed timeframes.
• Perform calibration on instruments, always ensuring that calibrations schedules are adhered to.
• Ensures appropriate maintenance of records.
• Participate in internal audit programme to ensure effective functioning of the quality systems
• Provide training and assessment of new staff and students.
• Attend meetings and training sessions as required, to remain informed of current field related developments and to promote knowledge sharing.

Administrative tasks

• Perform any required administrative tasks in keeping with the smooth running of the department
• File results for easy retrieval.
• Archive documents regularly
• Ensures appropriate maintenance of records.

Communication and co-ordination

• Liaise with suppliers – perform colour approvals at various printers.
• Liaise with suppliers and instrument engineers.
• Compile and submit reports timeously.
• Provide effective feedback on investigations and progress
• Give informed opinion on instruments and testing when required.