Quality Control Chemistry Associate
Cambridge, MA | Contract
Softworld Inc.’ s client is seeking a Quality Control Chemistry Associate I for a position based in Norwood, MA. The individual in this role will perform routine testing of raw materials and samples for mRNA products (in process, release and stability) manufactured at the client’ s facility. Also, this individual may support special projects as assigned. He/she will participate in troubleshooting assays and equipment and may support investigations for OOS and other non-conforming results.
Here’ s What You’ ll Do:
• Performs routine raw material and analytical chemistry testing including HPLC, UPLC, UV, CE
• Supports assay transfers and special projects as assigned.
• Completes and maintains cGMP testing documentation for work performed.
• Participates in authoring quality systems records such as deviations, change controls, CAPAs
• Troubleshoots assays and equipment.
• Supports investigations for OOS and other non-conforming results; may assist with investigations related to CMO/contract laboratory activities
• Performs data analysis and calculations
• Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
• Write/revise SOPs, protocols and reports
Here’ s What You’ ll Bring to the Table:
• Minimum education required: Bachelor’ s degree in a relevant scientific discipline
• Minimum experience required: 1+ years in a laboratory setting with focus in analytical chemistry
• Minimum knowledge required: cGMPs, HPLC, Wet Chemistry
• Minimum skills required: compendia chemistry test methods (e.g. conductivity, TOC), HPLC, UV, technical writing
• Strong written and oral communication skills as well as organizational skills
• Preferred Experience: LIMS, Chromeleon, Thermo UHPLC Instrumentation
• Knowledge of industry standards and guidelines, including USP/EP compendia testing requirements