Associate Scientist, QC
About The Position
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.
Requirements
- 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.
- Very strong experience with HPLC and GC
- Experience with FTIR, TGA, DSC, NMR
- 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.
Nice To Haves
- Experience with XRD, IC, ICP-MS and ICP-OES a plus but not a must.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
