Quality Control Analyst - Second Shift

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The QC analyst conducts routine and non-routine analyses and review of analytical data for raw materials, in-process samples, finished product, microbiology/ cleaning validation program, and other requested testing according to Standard Operating Procedures (SOP) and analytical methods in accordance with current Good Manufacturing Practices (CGMP) and regulatory requirements. Completes projects and testing with supervision. Has a clear understanding of Good Laboratory Practices (GLP), Good Documentation Practices (GDP), CGMP, 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 and Quality Assurance.

• Provide direct support to manufacturing department by testing/ reporting data for in process samples, meeting stringent schedules and deadlines
• Conduct analyses associated with clinical and commercial products under current Good Manufacturing Practices (CGMP) regulations and guidance per Food and Drug Administration (FDA) as well as International regulations
• Performs analyses, including biochemical and/or chemical analyses, on raw materials, in-process materials, active pharmaceutical ingredients (developmental and commercial), final product, and other requested testing according to established standard operating procedures
• Collaborate and communicate directly with manufacturing, project managers, and QC management
• Reviews data for compliance to specifications and reports/escalates abnormalities, as necessary
• Required to follow good documentation practices (GDP)
• Works cross-functionally to complete projects and testing
• Provides support for laboratory investigations and reports
• Participates in routine laboratory and equipment maintenance
• May perform special projects on analytical and instrument problem solving and troubleshooting
• May assist in mentoring or training others using increased knowledge and experience

• Bachelor of Science (B.S.) degree (Chemistry, Biology)
• At least 1-2+ years of relevant experience in analytical chemistry or related life sciences field industry, and/or equivalent combination of education, training, and experience
• Knowledge of analytical equipment and instrumentation: UV-Vis, Karl Fischer, HPLC/HPLC-MS, pH
• Proven ability to efficiently, accurately, and independently execute day to day tasks with minimal supervision
• Knowledge of computer software and hardware applications, including Microsoft Word and Excel

• Experience in CGMP, CDMO, and/or pharmaceutical settings
• Familiarity with Agilent instrumentation and software
• Knowledge of FDA and international regulations and guidelines (USP, JP, EP, ICH)