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.
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.
Recognize and report to immediate supervisor any issues or deviations from accepted standards.
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.
May participate in department initiatives and projects.
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.
Demonstrate analytical competency in the use and troubleshooting/maintenance of common analytical instrumentation e.g. HPLC/UPLC, Dissolution, GC, FTIR, UV/Vis.
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