- The QC Analyst will be responsible for conducting testing to support the introduction of new products or assist in investigation analysis of existing products.
- Conduct chemical and physical laboratory tests under minimal supervisor.
- Complete all testing in a timely manner that supports established production targets and SLAs.
- Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOPs and specifications.
- As a QC Analyst you will 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.
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
- Minimum of a bachelor’s degree qualification in Chemistry or Science with at least 12 months experience in a GMP environment
- Experience utilising analytical techniques such as HPLC and/or UPLC
- Demonstrate knowledge of cGMP requirements and practices including knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
- Experience in method validation and or transfer desirable but not essential.
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