Job Description
The Production Lead supports clinical trial projects through the packaging of clinical trial supplies; ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective and compliant processing through the shift. The Production Lead ensures that all lines have the proper staff, support, and training to execute the production batch records. This position reports to the Production Manager.
Education and Experience
Bachelor’s degree required or equivalent relevant work experience.
Minimum of 6 years of industry experience, clinical trial packaging, or related packaging/manufacturing/operations experience required.
Minimum of 4 years of leading teams.
Essential Functions
Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs.
Prepare and complete documentation in compliance with SOPs and cGMP.
Review packaging batch records for completeness and appropriate documentation and ensure that any corrections to the packaging batch record are completed accurately.
Inspect drug product, components, and clinical labels for defects, blemishes or missing text prior to and during production.
Proficiently perform Job Safety Analysis (JSA) on new equipment.
Ability to analyze processes, recommend changes and drive improvements.
Trained in the use of Entropy (safety system) and TrackWise (quality system).
Perform Gemba walks.
Use visual management boards and signage.
Support supervisor in daily activities.
Assist with Safety and Quality investigations, utilizing Root Cause Assessment techniques, and CAPA identification.
Must have a “Patient First” customer focus mindset.
Will reinforce and support a respectful and professional workplace among all team members.
Must be able to successfully manage competing priorities and personalities.
Provide front line leadership support and decision making to staff and act as supervisor for Packaging and Room operations when Supervisor is unavailable or needed.
Assist with action item completions (e.g., corrections in TrackWise).
Assist with scheduling planned maintenance activities for equipment and facilities and any corresponding return to service.
Attend project kickoff meetings and effectively contribute to the plan.
Monitor Ready-to-Execute and coordinate on-time start activities for production.
Review equipment and room setups against JSAs, batch records, and SOPs – make changes accordingly to drive compliance and productivity.
Capture daily information from Short Interval Control boards and populate daily shift notes as well as other required metric sheets.
Other duties as assigned.
Knowledge/Skills Requirements
Demonstrated ability to read, write, and communicate effectively.
Proven written and verbal communication skills.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work in a team environment.
Strong organizational skills in alignment of Lean Six Sigma 5S standards.
Ability to work effectively under pressure to meet competing workplace demands while maintaining the highest level of quality in all work performed.
Proficient computer skills – including, but not limited to e-mail, Microsoft Word, Microsoft Excel, Internet Explorer, Inventory Systems, Quality Systems, Supply Flex.
Strong mathematical skills.
Proven leadership and team management skills.
Ability to communicate and collaborate with external vendors if necessary.
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Education and Experience
Bachelor’s degree required or equivalent relevant work experience.
Minimum of 6 years of industry experience, clinical trial packaging, or related packaging/manufacturing/operations experience required.
Minimum of 4 years of leading teams.
Essential Functions
Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs.
Prepare and complete documentation in compliance with SOPs and cGMP.
Review packaging batch records for completeness and appropriate documentation and ensure that any corrections to the packaging batch record are completed accurately.
Inspect drug product, components, and clinical labels for defects, blemishes or missing text prior to and during production.
Proficiently perform Job Safety Analysis (JSA) on new equipment.
Ability to analyze processes, recommend changes and drive improvements.
Trained in the use of Entropy (safety system) and TrackWise (quality system).
Perform Gemba walks.
Use visual management boards and signage.
Support supervisor in daily activities.
Assist with Safety and Quality investigations, utilizing Root Cause Assessment techniques, and CAPA identification.
Must have a “Patient First” customer focus mindset.
Will reinforce and support a respectful and professional workplace among all team members.
Must be able to successfully manage competing priorities and personalities.
Provide front line leadership support and decision making to staff and act as supervisor for Packaging and Room operations when Supervisor is unavailable or needed.
Assist with action item completions (e.g., corrections in TrackWise).
Assist with scheduling planned maintenance activities for equipment and facilities and any corresponding return to service.
Attend project kickoff meetings and effectively contribute to the plan.
Monitor Ready-to-Execute and coordinate on-time start activities for production.
Review equipment and room setups against JSAs, batch records, and SOPs – make changes accordingly to drive compliance and productivity.
Capture daily information from Short Interval Control boards and populate daily shift notes as well as other required metric sheets.
Other duties as assigned.
Knowledge/Skills Requirements
Demonstrated ability to read, write, and communicate effectively.
Proven written and verbal communication skills.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work in a team environment.
Strong organizational skills in alignment of Lean Six Sigma 5S standards.
Ability to work effectively under pressure to meet competing workplace demands while maintaining the highest level of quality in all work performed.
Proficient computer skills – including, but not limited to e-mail, Microsoft Word, Microsoft Excel, Internet Explorer, Inventory Systems, Quality Systems, Supply Flex.
Strong mathematical skills.
Proven leadership and team management skills.
Ability to communicate and collaborate with external vendors if necessary.
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