Job Title: Associate Scientist, QC
Essential Responsibilities
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Perform HPLC, GC, FTIR, KF, DSC, TGA, NMR, etc.
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Inspect and perform complex chemical analyses on raw materials, in-process samples, and finished goods in accordance with cGMP/GLP standard operating procedures
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May be able to perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory.
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Coordinate raw material testing in a materials management system
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Conduct inspections of manufacturing supplies
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Conduct inspection of the laboratory or laboratory procedures to ensure conformance to internal quality system or external certification requirements and correct or eliminate process-related non-conformance items.
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Dispose of expired retained samples and chemicals according to schedules and expiration dates in order to keep lab area clean and safe.
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Experience with sampling raw materials and intermediates
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Coordinate the timely and compliant generation of data to support client projects
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Review data for technical content and good record keeping practices
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Other duties as assigned
Minimal Educational Qualifications
B.S. in chemistry with a minimum of 3+ years or M.S with a minimum of 1+ year of related pharmaceutical analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance is required.
Specific Skills and Requirements
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Very strong experience with HPLC and GC
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Experience with FTIR, TGA, DSC, NMR
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Experience with XRD, IC, ICP-MS and ICP-OES a plus but not a must.
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Experience with standard lab equipment (balances, pipettes, pH meter, UV-Vis, etc.)
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Be proficient in Microsoft Excel and Word
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Must have basic chemical knowledge and be able to handle materials safely.
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Must be able to communicate effectively with manufacturing and quality personnel.
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Must be able to effectively multitask.
