Also referred to as:
Clinical GMP Specialist II, GMP Compliance Audit Specialist II
Requirements and Responsibilities
Good Manufacturing Practices (GMP) Specialist II ensures day-to-day compliance with Good Manufacturing Practices by supporting manufacturing operations, quality systems, and documentation controls. Monitors manufacturing activities to verify adherence to GMP regulations, internal procedures, and quality standards. Being a Good Manufacturing Practices (GMP) Specialist II reviews batch records, logs, and controlled documents for accuracy, completeness, and regulatory compliance. Supports deviation investigations, corrective and preventive actions, and change control activities. Additionally, Good Manufacturing Practices (GMP) Specialist II assists with internal audits, regulatory inspections, and follow-up actions to address identified gaps. Provides guidance and training to production staff on GMP requirements and proper documentation practices. Requires a bachelor's degree. May require GMP certification (GMPCP). Typically reports to a manager. The Good Manufacturing Practices (GMP) Specialist II occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Good Manufacturing Practices (GMP) Specialist II typically requires 2-4 years of related experience.
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