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Chemist I
Analyze raw materials, finished products, and stability samples by HPLC and other specialized testing methodologies. Provide training and support to other QC lab personnel.


·        Test raw materials, finished products, stability samples by HPLC and other specialized testing methodologies (including proper documentation of all test results)
·        Test samples supporting process validations and cleaning validations (including proper documentation of all test results)
·        Perform method development and validation of test methods to support R&D activities and FDA submissions (including proper documentation of all test results)
·        Assist in the creation of written test methods as requested
·        Provide support for the complete testing of raw material/vendor qualification
·        Train and support QC lab personnel on testing procedures
·        Create standard operating procedures followed by the quality QC lab as requested
·        GC residual solvent method development and validation experience
 ·        GC Agilent 7890A experience with troubleshooting
 ·        GC testing by USP with packed and capillary column method optimization (USP) to development to verification and or validation experience
 ·        Advanced Empower software experience with custom field, report creation and optimization
 ·        Waters Acquity, UPLC experience with method development and troubleshooting and PM/IQ/OQ
·        Well versed with cGMP, cGLP and other guidelines (ICH, USP, FDA etc)
 ·        Maintain and qualify reference standards
·        Procure lab supplies, chemicals, glassware and equipment
·        Follow proper health and safety guidelines (i.e. PPE, safety regulations, etc.)
·        Work in accordance with all company policies and procedures
·        Perform other duties and special assignments as assigned
         Education and/or Experience:
·        Minimum BS degree in Chemistry or related field
·        3-5 years experience in a QC lab setting. Preferably in pharmaceuticals
·        Experience operating and programming HPLC
·        Experience using millennium and/or empower software
·        Familiarity with USP/NF and other compendia preferable
·        Experience in wet chemistry with some use of instruments
·        Ability to work independently with minimal supervision
On the job training:
·        MSDS/Hazardous Awareness
·        cGMP
·        Training to conduct tests for the release of raw materials, stability samples and finished products
·        IR spectrophotometer and UV/VIS spectrophotometer
·        HPLC and other instruments and complete testing of raw materials as per compliance requirements
·        appropriate SOP’s per department requirements
Reasoning Ability:
·        Ability to multi-task running equipment and documenting data
·        Perform mathematical calculations by hand or with software
·        Perform root cause analysis and troubleshoot problems
·        Ability to follow directions to accurately perform tests

·        Computer to create or update forms and documents use in the lab
·        Phone
·        Fax machine