Chemist II

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Job description

Job Description

The Chemist II perform the testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations which require chemical analysis.

* Physical and chemical testing of, raw materials, bulk, pre-fill, finished and stability products.
* Maintaining stability sample data sheet.
* Ensure all testing performed is properly documented in laboratory notebooks
* Performing peer review of work and documentation of other analysts work.
* Maintaining the work area in an orderly manner.
* Keeps current with all SOP's required to perform their job assignments.
* Reports any problems with assays or components to the QC Lab Supervisor.
* Responsible for preparing and standardizing any reagents or standard materials required for analysis.
* Reports any supply needs to the QC Lab Supervisor and lab coordinator.
* Disposes of unused samples and laboratory waste in appropriate containers.
* Performs calibration and verification of lab instruments as applicable.
* Revise SOPs, initiate and write change controls, method verification protocol and reports.
* Performs Analytical Method Verification and Transfer as required.
* Performs equipment troubleshooting and supports laboratory investigations.
* Maintain QC laboratory and equipment in good working order.
* Assign and monitor Lab Technician and Chemist I job assignments as required. Train and mentor Lab Technician and Chemist I as required.

Qualifications

* BA or BS in chemistry with five years of experience in a lab performing chemistry related duties.
* Experience with High Pressure Liquid Chromatography, Infra-Red (IR), Gas Chromatograph (GC), Ultra Violet/Visible, Particle Size Analysis, KF Titration and wet chemistry skills is required. Familiarity with HPLC/GC analytical software.
* Familiarity with GLP/GMP guidelines.
* Good Communication and writing skills.
* Familiarity with out-of-specification (OOS) and out - of -trend (OOT) investigations
* Write OOS and OOT reports
* Computer literate.
* Experience with USP/EP monographs.
* Must be detail oriented.
* Flexibility and adaptability in an ever-changing, fast paced environment is essentia
* Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
* Must have a team work attitude.