Jessie Schrot Email & Phone Number

Dedicated and detail-oriented professional with extensive experience in pharmaceutical quality control, specializing in cGMP compliance. Proven track record of ensuring product quality and regulatory compliance within the pharmaceutical industry. Adept at utilizing advanced analytical techniques and instrumentation to perform accurate and reliable quality assessments. Strong team player with exceptional communication skills and a commitment to continuous improvement.Skills:cGMP Compliance: In-depth understanding of current Good Manufacturing Practices and their application in the pharmaceutical industry. Proficient in interpreting and implementing regulatory guidelines to ensure product quality, safety, and compliance.Analytical Instrumentation: Expertise in operating and maintaining a wide range of advanced analytical instruments such as HPLC, GC, FTIR, UV-Vis, and more.Documentation and Reporting: Strong ability to maintain comprehensive and accurate documentation of quality control activities, test results, and compliance records. Proficient in writing detailed technical reports and summaries.Root Cause Analysis: Experienced in investigating and troubleshooting deviations, out-of-specification results, and other quality-related issues. Skilled in identifying and addressing root causes to prevent reoccurrence.Regulatory Knowledge: In-depth knowledge of regulatory requirements, including FDA guidelines and international standards (ICH, USP, EP). Able to participate in regulatory inspections and audits.Cross-functional Collaboration: Strong interpersonal skills that facilitate effective collaboration with various departments such as production, research and development, and quality assurance to ensure a holistic approach to quality control.Leadership and Training: Experience in training and mentoring junior staff members in laboratory techniques, quality control procedures, and compliance practices.By combining these skills with a comprehensive understanding of pharmaceutical quality control and cGMP principles, I am dedicated to ensuring the highest level of product quality, regulatory compliance, and continuous improvement in the pharmaceutical manufacturing process.

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  Northern Michigan University

  Biology