Plant Qc Specialist Ii

The Quality Assurance Chemist will carry out sampling and testing according to standard operating procedures.
- Ensure all activities meet GMP and ISO guidelines as specified by FMC quality system and training.
- Ensure all activities are carried out in a safe manner and according to Workplace Health and Safety regulations.
- Sampling and testing of packaging materials, raw materials, intermediate products and finished products to verify they meet specifications.
- Assist production staff in relation to any information or guidance required for quality issues in conjunction with Laboratory management.
- Ensure compliance for laboratory activities undertaken within FMC guidelines.
- Temperature and pressure monitoring of the plant.
- Send samples to approved contract testing laboratories.
- Preparation of solutions and reference standards.
- Approve all chemical reagents before use.
- Check the calibration status of all laboratory equipment before use. Ensure that all laboratory equipment is calibrated as per the calibration schedule.
- Ensure laboratory data is recorded on the appropriate registers.
- Perform stability testing on haemodialysis solutions as per the stability studies schedule.
- Maintain orderly storage of retention samples.
- Notify the QA Manager / Lab Supervisor of any discrepancies or out of specification results immediately.
- Only approve products for further processing that test within specification.
- Ensure the lab supervisor is advised of any low stock materials used in the laboratory including chemicals and glassware.
- Ensure that all data is recorded on the correct forms in real time.
- Ensure that changes to any recorded data are only made in the correct manner and signed and dated as per training.
- Assist in internal audits for compliance with FMC quality systems.
- Carry out other projects as directed by the Quality Assurance Manager/ Laboratory Supervisor.