Analyst II, QC Aseptic Control, Lead (Day Shift)

Job Responsibilities

• Schedule work and load the correct pulls in Environmental Monitoring System
• Troubleshoot methods and processes
• Develop methods and processes
• May serve as the primary link between QC team and Operations for day-to-day activities, such as schedules and workload planning
• Cook up workflow in Environmental Monitoring team
• Verify QC data while monitoring for trends and abnormalities
• Maintain training to perform all Environmental Monitoring technician responsibilities (including maintaining aseptic qualification) when needed
• Review completed production documentation (for example: logbooks) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance
• Assign work tasks and activities to others
• Train others on systems, software, equipment, machines, procedures, and/or processes
• Answer compliance and process questions from others
• Communicate policies and procedures to employees
• Fill in for immediate supervisor when needed
• Gather, organize, and communicate operational information to others
• Lead and coordinate investigations and studies with little supervision
• Lead process improvement activities and teams to meet strategic goals
• Communicate priorities and progress to team on a continuing basis
• Ensure that employees have the tools needed to perform their jobs
• Monitor training of employees to ensure compliance

Minimum Requirements

• Prior experience in a pharmaceutical production or quality control environment
• Effective understanding, reading, writing, communication, and following instructions in the English language
• Thorough attention to detail because individual must be capable of keeping accurate records and performing mathematical calculations

Preferred Background

• Bachelor’s degree in scientific discipline
• Prior experience in a sterile or cGxP environment