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QC Analyst II - (1st shift)
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
Conducts routine and non-routine analysis and reviews of analytical data for raw materials, in-process, microbiology/ cleaning validation program and other requested testing according to Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. Completes projects to with supervision. Has a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements. Actively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalates issues to QC management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers and management. * Conducts analysis associated with clinical and commercial under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) as well as International regulations. * Performs analysis on raw materials, in-process materials, APIs (developmental and commercial), final product and other requested testing as per written procedures. * Reviews data for compliance to specifications, and reports and troubleshoots abnormalities. * Ensures equipment is performing well and communicates and takes appropriate action as necessary. * Required to follow good documentation practices. * Works cross-functionally to complete projects and testing
* Bachelor's degree (B.S.) or equivalent experience in Analytical Chemistry or related life sciences field * 2+ years industry experience and/or training; or equivalent combination of education and experience. * Proven knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support the production of APIs, stability and drug product release. * Demonstrated knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferred * Knowledge of FDA regulations and guidelines * Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives * Personal leadership skills and fosters working in a team environment * Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
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