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
- 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.
- Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
- The QC Analyst will provide status updates on own activities and productivity challenges according to defined procedures.
- 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.
- Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses
- Minimum of a bachelor’s degree qualification in Chemistry or related Science.
- Minimum 2 years relevant laboratory experience in a cGMP environment.
- 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.
- Demonstrate analytical competency in the use and troubleshooting/maintenance of common analytical instrumentation e.g. HPLC/UPLC, Dissolution and GC.
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