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. The QC Analyst is responsible for the safe, compliant, and efficient execution of job duties in a team environment.
- 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.
- Participate in investigations and root cause analysis.
- The QC Analyst will 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.
- The QC Analyst will complete and conform to all training requirements for job role, including company-required and job role-specific training.
The next QC Analyst should have a degree in Science with at least 12 months experience working in a GMP enviornment carrying out analytical testing. You should have storng experience with HPLC/UPLC and demonstrate excellent communication and problem-solving skills.
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