The QC Analyst, 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 position reports to the QC Supervisor, Tech transfer and may act as his/her deputy as deemed necessary.
- Conduct chemical and physical laboratory tests under minimal supervisor.
- Complete all testing in a timely manner that supports established production targets and SLAs.
- The QC Analyst will 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.
- The QC Analyst 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.
- The QC Analyst will 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.
The next QC Analyst should have a bachelor’s degree in Science with at 2 years industry experience working with analytical techniques such as HPLC/UPLC and GC. Technical Transfer or Method Development would be beneficial but not required.
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