The QC Chemist as part of the technical transfer group is responsible for conducting testing to support the introduction of new products or assist in investigation analysis of existing products. This testing may include raw material, in process and finished product according to relevant SOPs. The QC Chemist applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfilment of the assigned performance targets.
- Conduct chemical and physical laboratory tests under minimal supervisor.
- Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOPs and specifications.
- Observe established escalation process for laboratory issues that impact established production-related Service Level Agreements (SLAs) and/or the fulfilment of production goals.
- Participate in investigations and root cause analysis.
- Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, analytical test methods, method development/validation protocols and reports and method verification protocols and reports.
- Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
- May participate in department initiatives and projects.
The next QC Chemist should have a BSc. in science or Engineering with at least 1 years experience utilising HPLC/UPLC analytical techniques.
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