Chemist
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.
PRIMARY RESPONSIBILITIES:
· 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
QUALIFICATIONS:
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
Training:
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
TOOLS AND EQUIPMENT:
· Computer to create or update forms and documents use in the lab
· Phone
· Fax machine