Description

Reporting to the QC Supervisor, the QC Chemist is responsible for raw material, in-process, isolated intermediate, or finished good testing in a GMP laboratory environment.  The QC Chemist III will provide technical knowledge to the role and assist junior staff with troubleshooting activities as necessary.

• Follow all FDA, ICH, cGMP, cGLP, DEA, and internal SOP requirements as they related to Phase III and commercial GMP laboratory operation.
• Adhere to all OSHA and company safety requirements and practices.
• Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability.
• Support/maintain laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ.
• Perform in-depth out of specification or out of trend laboratory investigations of non-complying or aberrant results.
• Support the implementation and training efforts for new laboratory instrumentation or software.
• Perform data review of QC data as necessary.
• Independently perform troubleshooting of laboratory equipment.
• Strong working knowledge of HPLC, UPLC, GC, and GC-HS.
• Working knowledge of wet chemistry.
• Write controlled documents such as reports, test procedures, SOPs, etc.
• Evaluate validity of test results.
• May assist in training employees within the department. Topics may include, but are not limited to, instrumentation, analytical concepts, or equipment troubleshooting.
• Perform and document method transfer from Analytical Development. May perform method evaluation experiments as necessary.
• Handle, analyze and dispose of hazardous samples and waste.
• May need to provide off-shift coverage as required.
• Maintain laboratory solutions, inventory and notebooks utilizing a LIMS.
• Coordinate and communicate project status with a proven ability to handle various assignments and organize workload to meet timelines.
• May interact with outside vendors and other departments.
• Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at Cambrex Charles City.
• Proven ability to handle various assignments and organize workload to meet timelines.
• May act as departmental subject matter expert (SME).

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental objectives and assignments not specifically detailed in this section may be assigned.

• BS/BA in Chemistry/Biology or related science field require

PI278705336