Roberto Chavez-Ruiz

The Quality Analyst is responsible for supporting quality operations within a pharmaceutical warehouse environment. This role ensures compliance with Good Manufacturing Practices (GMP), company Standard Operating Procedures (SOPs), and regulatory requirements by overseeing documentation, batch control, and record retention activities.

Key Responsibilities

• Review, manage, and maintain quality-related paperwork and warehouse documentation in compliance with GMP and regulatory standards
• Ensure proper documentation practices (GDP) are followed at all times
• Manage retention periods for records, samples, and documentation according to company and regulatory requirements
• Place pharmaceutical batches on quality hold when required and ensure proper labeling, segregation, and documentation
• Support batch release activities by verifying completeness and accuracy of records
• Ensure warehouse operations follow approved SOPs, work instructions, and quality procedures
• Identify documentation discrepancies and work with cross-functional teams to resolve issues
• Participate in audits, inspections, and internal quality reviews as needed
• Maintain accurate logs, trackers, and quality systems related to warehouse activities

Job Summary

The Team Lead in the Preparation Department is responsible for overseeing daily warehouse preparation activities to ensure pharmaceutical products are accurately picked, staged, and prepared in compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements. This role provides hands-on leadership, ensures workflow efficiency, and maintains the highest standards of quality, safety, and documentation.

Key Responsibilities

• Lead and coordinate daily operations within the preparation department, including picking, staging, and material preparation
• Ensure all preparation activities comply with GMP, GDP, and approved SOPs
• Assign tasks, monitor performance, and provide guidance and support to team members
• Verify accuracy of prepared orders, batch documentation, and labeling prior to release to the next process
• Ensure proper handling, storage, and segregation of pharmaceutical materials and controlled substances
• Address and escalate discrepancies, deviations, or quality issues in a timely manner
• Support training of new and existing employees on procedures, safety, and quality requirements
• Maintain a clean, organized, and audit-ready work environment
• Collaborate with Quality, Warehouse, and Operations teams to meet production and shipment timelines
• Participate in audits, inspections, and continuous improvement initiatives

Qualifications

• Prior experience in a pharmaceutical or regulated warehouse environment preferred
• Strong understanding of GMP, SOPs, and quality compliance
• Leadership or supervisory experience in warehouse or operations settings
• Strong attention to detail, organizational, and communication skills
• Ability to lead by example in a fast-paced, regulated environment

Work Environment

• Pharmaceutical warehouse / preparation area
• Requires adherence to strict quality, safety, and regulatory standards