Quality Control Analyst

Hello, Hope you are doing great. This is Karthik from Intellectt INC; we have an immediate opportunity. Please find the below job description and if you are interested, please forward your resume to Role: Quality Control Analyst - R&D Project Location: Portland OR Duration: Long Term OBJECTIVES:

• Perform activities for general lab readiness, laboratory equipment qualification, and method transfers.
• Conduct critical biological test methods including samples generated for in-process, drug substance, and stability.
• Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS and Empower).
• Independently prioritize and perform routine and non-routine methods requiring precise analytical skills and understanding of biology and chemistry principles.

• Demonstrate an in-depth theoretical understanding of laboratory operations, systems, and methods.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
• Independently exercise judgment for broadly defined practices, procedures, and policies to select methods, techniques, and evaluation criteria. Obtains results, troubleshoots problems, and formulates solutions.
• Decisions have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.
• Serve as a point person for particular assays and/or equipment and systems.
• Work within laboratory environment for extended periods of time, conducting analytical tests, reviewing analytical data, maintaining laboratory materials and instruments and other laboratory functions as required
• Perform laboratory instrument qualification.
• Initiate and own deviations, CAPAs, and change controls within the electronic Quality Management System.
• Drafts studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors.
• Revises and authors new SOPs and study documentation.
• Receives minimal instruction on new assignments.
• Provides mentoring, training and may serve as Lab Lead to direct work of lower level QC Analysts.

• Bachelor's or Master's Degree in any Life Sciences with relevant laboratory coursework
• 4+ years of relevant experience preferred.
• Preferred strong background in High Performance Liquid Chromatography (HPLC) and Ultraviolet-Visible Spectroscopy (UV-Vis).
• It is desirable that the candidate has experience with Total Organic Carbon (TOC) analysis and Capillary Electrophoresis (CE), but not required.
• The ideal candidate would have experience working in a commercial Pharmaceutical Quality Control laboratory.