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. The QC Chemist is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports to the QC Supervisor, Tech transfer and may act as his/her deputy as deemed necessary.
- The QC Chemist will conduct chemical and physical laboratory tests under minimal supervison.
- 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.
- Observe established escalation process for laboratory issues that impact established production-related Service Level Agreements (SLAs) and/or the fulfillment of production goals.
- QC Chemist 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.
- Recognize and report to immediate supervisor any issues or deviations from accepted standards.
- The QC Chemist 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.
- The QC Chemist may participate in department initiatives and projects.
- Bachelor’s Degree qualification in Chemistry or related Science with2 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, GC, FTIR, UV/Vis.
- Demonstrated success in preparing and delivering presentations.
- Computer literate; proficiency in using Microsoft Office suite, and laboratory software such as Empower and LIMS. Technical writing.
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