Associate Scientist, QC

Job Title: Associate Scientist, QC

Essential Responsibilities

• Perform HPLC, GC, FTIR, KF, DSC, TGA, NMR, etc.
• Inspect and perform complex chemical analyses on raw materials, in-process samples, and finished goods in accordance with cGMP/GLP standard operating procedures
• May be able to perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory.
• Coordinate raw material testing in a materials management system
• Conduct inspections of manufacturing supplies
• 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.
• Dispose of expired retained samples and chemicals according to schedules and expiration dates in order to keep lab area clean and safe.
• Experience with sampling raw materials and intermediates
• Coordinate the timely and compliant generation of data to support client projects
• Review data for technical content and good record keeping practices
• 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

• Very strong experience with HPLC and GC
• Experience with FTIR, TGA, DSC, NMR
• Experience with XRD, IC, ICP-MS and ICP-OES a plus but not a must.
• Experience with standard lab equipment (balances, pipettes, pH meter, UV-Vis, etc.)
• Be proficient in Microsoft Excel and Word
• Must have basic chemical knowledge and be able to handle materials safely.
• Must be able to communicate effectively with manufacturing and quality personnel.
• Must be able to effectively multitask.