The Chemist is responsible to oversee the conduction of quantitative and qualitative analysis raw materials used for productions according to FDA, Good Laboratory Practices (GLP's), Current Good Manufacturing Practices (cGMP's) and Standard Operating Procedures (SOP's). Duties include performing analysis of Raw Materials using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development according to USP/EP methods.
Specific Responsibilities & Duties:
- Promotes a safe working environment and adheres to Health, Safety and Environmental procedures, company safety rules, Good Laboratory Practices (GLD's), Current Good Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's) at all times.
- Manages a team to perform Analytical tests on raw materials in compliance with GMP and as directed by the QC Specifications.
- Performs physical and chemical testing primarily on raw materials per Raw Material Specifications, USP-NF or other compliance requirements.
- Performs identification tests including FTIR, UV-VIS.
- Performs Physical tests including color, odor, appearance, PH, Solids/Loss on Drying, Ash, Moisture, Melting point, Viscosity, Specific Gravity and Refractive Index.
- Performs Chemical tests and assays, using manual titration or with auto titrator.
- Performs assay tests on active raw materials using HPLC, GC and UV-Visible spectrophotometry.
- Responsible for OTC active raw material annual confirmation project and associated testing.
- Release raw materials in Material Management system after approval.
- Performs calibration and routine maintenance of laboratory equipment as needed.
- Conducts laboratory work and associated record keeping in a safe manner and in keeping with generally recognized GLP/GMP/GDP.
- Completes OOS reports in a timely and accurate manner.
- Perform other duties as assigned by QA Lab Manager/Director.
- Capable of lifting up to 25 lbs.
- Capable of standing, walking, and sitting for extended periods
- High school education or equivalent.
- Bachelor of science; Chemistry field preferred.
- Must have a minimum of 2 years' experience in Quality Control preferably in analytical filed
- Must have 1-year leadership role experience in a laboratory environment
- Must be able to maintain a clean, sanitary, and organized work area. Maintains housekeeping in conformance with Good Laboratory Practices (GLD's), Current Good Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's)
- Full knowledge of working with and troubleshooting analytical instrumentation.
- Good time-management skills
- Good English communications skills: speaking, reading, and writing.
- Advanced PC Knowledge i.e. MS Office Suite (Excel, Word, Outlook) is preferred
- Flexibility to work long hours during peak season or special schedules as needed to satisfying job requirements.
- Ability to multi-task and follow through on project assignments
- Ability to quickly remedy procedural problems
- Good interpersonal and customer service skills
- Excellent organizational and planning skills
- Makes suggestions for improvements
- Communicates and collaborates with management
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