QC Analyst

Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBIs 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 QC Analyst. The successful incumbent will be required to:

Ensure quality, safety and efficacy of products through quality control processes applying the principles of good laboratory practice and good manufacturing practice.

Applications are invited from suitably qualified and experienced candidates.

Specific Operational Requirements

• The successful candidate will be required to work an 8 hour shift between 06:00 to 18:00.
• Candidate must have access to reliable transport.
• May be required to work overtime to meet the business needs.
• Must be prepared to work shifts/weekends/public holidays when needed.

• 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.

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 SOPs for new equipment / methods.
• Continuously review existing SOPs 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.

Information :

• Company : NBISA Recruitment
• Position : QC Analyst
• Location : Pinetown, KwaZulu-Natal
• Country : ZA