This position performs operational, administrative, and logistical activities in support of the manufacturing/packaging of drug products and providing supervisory level leadership to indirect reports. The preferred candidate blends working knowledge equipment and processes with an understanding of lean concepts to drive a culture of ownership and continuous improvement.
Shift - Monday - Thursday 8:00pm to 6:30am
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Provides routine One-on-One feedback to individuals on the team
• Provides input to shift supervisor regarding individual/team performance
• Performs production duties in area/line
• Leads Root Cause Problem Solving (RCPS) sessions to drive continuous performance and quality improvement
• Reviews and approves shift reports in CDC Factory on a daily basis
• Creates, implements and executes a quarterly improvement plan for area/line
• Works with Maintenance to predict and prevent unplanned downtime
• Generates work orders as required for maintenance support
• Remediates and acknowledges BAS alarms
• Initiates quality investigations and executes CAPAs (Corrective and Preventative Actions)
• Performs reviews and approvals of completed batch records
• Ensure all appropriate training requirements are assigned in LMS
• Maintains a flexible work force through cross-training
• Utilizes daily direction setting to achieve area goals and determine need for overtime
• Act as first responder to safety and quality events
• Provides input to shop floor schedule
• Assists supervision with vacation scheduling
• Performs job functions in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Batch Record instructions
• Performs additional related duties as assigned
Equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
• Requires a high school diploma or equivalent
• Prefer associates or technical degree
• Requires a minimum of 3 years of relevant experience in a regulated industry
• Prefer previous experience in a leadership role
• Motivate and lead others
• Computer proficiency with knowledge of automated systems (i.e. ERP) preferred
• Self-directed with ability to organize and prioritize work
• Communicate effectively with written and oral communication skills
• Interact positively with co-workers, team, and supervision
• Works on problems of moderate scope where analysis of situation or data requires knowledge and evaluation of identifiable factors.
• Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.
• Normally receives minimal-to-moderate instruction on routine work and receives detailed instructions on new assignments
• Proactively recommends methods and procedures for problem resolution
• Required to routinely wear personal protective equipment such as safety shoes, safety glasses, powered air purifying respirator, gloves, etc
• May be required to stand for prolonged periods of time
• Occasionally lifting or moving heavy objects up to 50 pounds