Senior Specialist Data Review - MD-MV Analytical Chemistry

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Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Education/Experience (BMQ): Master's degree in a science-related field with 7-10 years of experience in Pharmaceutical Chemistry drug product/substance testing with knowledge of regulatory requirements. Theoretical / Practical experience with analytical techniques such as pH meter, Spectroscopy (UV, IR,), Chromatography assay/imps (HPLC/UPLC, GC, IC...etc.), Analytical method validations data review, knowledge of USP/EP compendia, ICH guidance, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred. Abilities and/or Skills: Honest, Dependable, Demonstrated Ability to Self-Manage Detail Oriented, Accurate, Precise Strong Math Skills Strong Organizational Skills Logical Thinking, Good Reasoning Ability Strong communication including verbal, writing, and presentation skills Dedication to quality, ethics, and customer service Ability to handle personal stress Mental and emotional stability and maturity Motivation to excel Should be able to sit for long periods as per role requirement Team Lead experience

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Company Intel

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