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.