Night Shift Team Lead: Clinical Trial Packaging

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision benefits from

8 holidays PTO

Tuition reimbursement

Career growth opportunities

Job summary

Catalent Pharma Solutions in Kansas City, MO, seeks a CSS Team Lead for 3rd shift to supervise packaging of clinical trial supplies and ensure compliance with GMP and SOPs. The role emphasizes on-time startup, shift leadership, and staff training.

You will review batch records, inspect products, perform safety analyses, and drive process improvements using Entropy and TrackWise. Strong communication and 5S discipline are required, along with a DEA background check and PPE requirements.

Qualifications

• High School degree or equivalent; Bachelor's degree in a science-related field preferred.
• Experience in clinical trial packaging or related packaging, manufacturing, or operations.
• Ability to read, write, and speak English effectively.
• Strong written and verbal communication skills.
• Team-oriented with strong organizational skills aligned with 5S standards.
• Proficient with MS Word, Excel, Internet Explorer, inventory systems and quality systems.

Responsibilities

• Review packaging batch records before processing to ensure instructions follow standard operating procedures.
• Prepare and complete documentation in compliance with standard operating procedures and current good manufacturing practices.
• Review packaging batch records for completeness and accuracy, ensuring corrections are properly made.
• Inspect drug products, components, and clinical labels for defects or missing text before and during production.
• Perform Job Safety Analysis on new equipment.
• Analyze processes, recommend changes, and drive improvements.
• Use Entropy (safety system) and TrackWise (quality system) effectively.
• Conduct Gemba walks and use visual management boards and signage.
• Support the supervisor in daily activities and assist with safety and quality investigations using Root Cause Assessment and CAPA identification.
• Promote a “Patient First” mindset and maintain a respectful, professional workplace.
• Manage competing priorities and provide front-line leadership support when the supervisor is unavailable.
• Assist with action item completions, maintenance scheduling, and project kickoff meetings.
• Monitor Ready-to-Execute and coordinate on-time production start activities.
• Review equipment and room setups for compliance and productivity improvements.
• Capture daily information from Short Interval Control boards and complete required shift documentation.
• Perform other duties as assigned.

Skills

Leadership

Team management

Communication

5S standards

English proficiency

Quality systems

Education

Bachelor's degree in a science-related field

High School diploma or equivalent

Tools

Entropy

TrackWise

Microsoft Word

Microsoft Excel

Inventory systems

Quality Systems

Job description

Catalent Pharma Solutions in Kansas City, MO, seeks a CSS Team Lead for 3rd shift to supervise packaging of clinical trial supplies and ensure compliance with GMP and SOPs. The role emphasizes on-time startup, shift leadership, and staff training.

You will review batch records, inspect products, perform safety analyses, and drive process improvements using Entropy and TrackWise. Strong communication and 5S discipline are required, along with a DEA background check and PPE requirements.