Quality Operations Specialist 503B (2nd shift)

Position Summary The Quality Operations Specialist ensures consistent delivery of safe, sterile, and compliant pharmaceutical products, directly impacting patient outcomes and regulatory standing. This role owns quality oversight across manufacturing review, deviation management, and compliance assurance within a fast-scaling 503A/503B environment. Leveraging AI as a force multiplier, the Specialist enhances review speed, improves deviation detection, strengthens root cause analysis, and enables data-driven decision-making at scale. Operating with high autonomy, this role integrates quality into operational execution while continuously improving systems and processes. Responsibilities Quality Execution Batch Review: Conduct detailed review of cGMP batch records and manufacturing documentation, using AI-enabled validation tools to identify discrepancies, improve accuracy, and accelerate throughput. Process Monitoring: Monitor manufacturing activities to ensure adherence to aseptic techniques, cleanroom standards, and operational procedures. Release Support: Support product release readiness by verifying data integrity and completeness while ensuring alignment with regulatory expectations and quality standards. Deviation and Investigation Deviation Handling: Identify, document, and support triage of deviations, ensuring timely escalation and compliance with internal procedures and regulatory requirements. Root Cause Analysis: Perform structured root cause analysis using data-driven methodologies to uncover underlying issues and support effective corrective actions. CAPA Support: Assist in the development and implementation of corrective and preventive actions, tracking effectiveness and closure. Compliance and Efficiency Regulatory Adherence: Execute quality processes in alignment with FDA and state regulations within a 503A/503B environment. Environmental Monitoring: Perform and support environmental monitoring activities to ensure compliance with sterility and contamination control standards. Operational Support: Collaborate with cross-functional teams to resolve quality issues, improve workflows, and support high-quality execution. Experience and Qualifications Minimum of 4 years of directly related experience. Bachelor of Science in a science-related discipline required. Strong attention to detail, organizational, and prioritization skills. Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Outlook. Experience in sterile and non-sterile manufacturing and knowledge of state and federal regulations required. Knowledge and Skills Strong knowledge of cGMP regulations, sterile and non-sterile manufacturing processes, and quality systems. Proficiency in data analysis, root cause investigation methodologies, and CAPA processes. Strong organizational, prioritization, and multitasking skills in fast-paced, regulated environments. Effective communication and cross-functional collaboration skills. Key Competencies Customer Focus: Builds trust through customer-centric solutions. Strategic AI: Guides responsible AI adoption and adaptation. Optimizes Work Processes: Drives efficiency with continuous improvement. Collaborates: Partners effectively to achieve shared goals. Resourcefulness: Secures and deploys resources efficiently. Manages Complexity: Simplifies and solves complex challenges. Ensures Accountability: Delivers on commitments with integrity. Situational Adaptability: Adjusts approach to shifting conditions. Communicates Effectively: Tailors messages to diverse audiences. Physical Requirements While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. #J-18808-Ljbffr Empower Pharmacy