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Scientist
3 months ago
The Scientist I will be working under the supervision of the Pharma QC Lab Supervisor and will be responsible for non-routine method development and validation, routine analysis and testing, equipment calibration and maintenance, and routine product release sample analysis and stability analysis.
- Performs development and analytical validation/verification activities per USP and ICH criteria.
- Ability to validate HPLC, GC and dissolution methods and generate appropriate and accurate protocols and reports.
- New equipment validation
- Follows in-house procedures to complete testing.
- Suggests possible improvements to current testing.
- Organizes and prioritizes testing workload to achieve goals and objectives.
- Verify like work performed by other analysts.
- Prepares documents suitable for FDA (Federal Drug Administration) submissions.
- Conducts routine OOT/OOS investigations to determine root cause.
- Performs trending activity to aid in investigations.
- Updates/Revises SOPs to comply with current standards.
- Performs routine equipment calibrations as specified by SOP.
- Performs routine laboratory maintenance as specified by SOP.
- Routinely maintains a clean work area.
- Other duties as assigned.
- Bachelor's degree in Chemistry, Biochemistry or other related field.
- Extensive experience with equipment and validation and development of methods.
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- Ensuring growth opportunities for our people
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