Operations Compliance Specialist

Job Summary The Operations Compliance Specialist is responsible for ensuring that compliance in production areas is adhered to at all times. This includes reviewing SOPs, identifying gaps in SOPs and processes, and implementing appropriate CAPA, change control, and risk mitigation provisions to achieve 100% compliance. The role requires a thorough understanding of FDA GMP requirements, pharmaceutical technical processes, and the ability to communicate complex technical problems in clear, straightforward language, both verbally and in writing. Core Responsibilities Provides leadership to production staff for compliance-related matters. Conducts thorough GAPA analysis for production quality systems and processes, identifying opportunities for risks and placing appropriate mitigation measures. Coaches and mentors compliance investigators on root cause analysis and CAPA implementation to prevent recurrences. Acts as a subject‑matter expert on behalf of production for continuous improvement, facility expansion, and process improvement projects. Acts as a subject‑matter expert during regulatory audits. Monitors trends and conducts trend analysis for deviations, change controls, and CAPAs to understand patterns and provide findings to production management with alternate solutions. Provides training and awareness to educate employees in in‑scope business areas on emerging risks, issues, and policy requirements. Engages in routine interaction with site management, including compiling spreadsheets to communicate investigational status and CAPA discussions. Works on the production floor for data gathering and observes processes for enhanced compliance. Performs other duties as assigned. Qualifications & Requirements Associate or bachelor’s degree in a scientific field or 3‑5 years of extensive experience in the pharmaceutical industry, preferably in product manufacturing with demonstrated experience in quality functional areas. Excellent problem‑solving skills. Working knowledge of root cause analysis tools. Excellent technical writing skills. Expert knowledge of manufacturing operations. Proficiency with Microsoft Word, Excel, and PowerPoint. Position Type On‑Site Travel None As set forth in Harrow, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. #J-18808-Ljbffr Harrow, Inc.