QC Scientist - Raw Materials
$64,480–$83,200 year
On-site · Gaithersburg, Maryland, United States or Frederick, Maryland, United States
Job Summary
QC Scientist to launch and support a new raw materials testing facility. Performs raw materials testing per GxP with SOPs and compendial chapters; executes wet chemistry, HPLC/UPLC/GC, and FTIR analyses; documents testing activities in data capture forms and electronic notebooks; evaluates data against specifications and reports abnormalities; troubleshoots instruments and maintains equipment; owns minor deviations, simple change controls, and CAPAs; writes and revises SOPs; conducts logbook/data/document review; supports implementation of new methods/technologies; maintains Lean/Six Sigma in lab operations including inventory and sample handling; collaborates within a team in a start-up lab environment; training conducted in Gaithersburg, MD and Frederick, MD.
Required Qualifications
- BS in Chemistry, Biochemistry, or related scientific discipline
- Minimum 3 years of relevant pharmaceutical QC experience; wet lab experience required
- Hands-on experience with raw materials testing
- Experience with compendial and physiochemical testing (appearance, pH, wet chemistry)
- Experience with HPLC/UPLC, GC, and FTIR
- Ability to work with USP/NF, Ph. Eur., and JP general chapters and monographs
- Strong documentation skills and understanding of cGMP requirements
- Proficiency in Microsoft Outlook, Excel, and Word
- Authorization to work in the U.S. without sponsorship
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