Team Lead - 3rd Shift

Catalent Pharma Solutions•Kansas City, MO

2d•Onsite

About The Position

We have an opportunity for a CSS Team Lead - 3rd Shift to join our team supporting clinical trial projects through the packaging of clinical trial supplies. This role ensures all work is performed in compliance with regulatory requirements, good manufacturing practices, and standard operating procedures. The position oversees the process for the area, ensuring on-time startup and effective, compliant processing throughout the shift. The Team Lead provides staff support, training, and leadership to ensure successful execution of production batch records.

Requirements

High School degree or equivalent required; bachelor’s degree in a science-related field preferred.
Experience in clinical trial packaging or related packaging, manufacturing, or operations required.
Ability to read, write, and speak English effectively.
Strong written and verbal communication skills.
Ability to interpret written, oral, diagram, or schedule instructions.
Team-oriented with strong organizational skills aligned with 5S standards.
Ability to work effectively under pressure while maintaining high quality standards.
Moderate to advanced computer skills, including Microsoft Word, Microsoft Excel, Internet Explorer, Inventory Systems, and Quality Systems.
Basic mathematical skills.
Proven leadership and team management abilities.
Ability to communicate and collaborate with external vendors when necessary.
20/30 corrected vision exam required.
Respirator fit testing and pulmonary physical required.
Handling of controlled substance product requires a DEA background check.
Operation of a manual pallet jack required; may become licensed to operate the Pallet Stacker as needed.
Must be available to work occasional overtime.

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.