This position performs operational, administrative, and logistical activities in support of the manufacturing/packaging of drug products and providing front line leadership to direct 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 - Friday through Sunday from 6:00pm to 6:30am
ESSENTIAL AREAS OF RESPONSIBILITY
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.
• Performs production duties in area/line
• Leads Root Cause Problem Solving (RCPS) sessions to drive continuous performance improvement
• Implements and maintains lean, zero loss, and ownership culture to improve equipment and personnel efficiency
• Develops and maintains shift and department metrics, i.e. performance boards
• Creates, implements and executes a quarterly plan for area/line
• Works with Maintenance to predict and prevent unplanned downtime
• Assists with quality investigations and CAPAs (Corrective and Preventative Actions)
• Performs reviews and approvals of completed batch records
• Creates, revises, reviews and approves Standard Operating Procedures (SOPs)
• Completes all training requirements and maintains 100% team compliance with all assignments
• Provides routine One-on-One feedback with direct reports
• Responsible for coaching and developing reports
• Responsible for assisting with shop floor schedule planning and adherence
• 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 and management
• 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 instruction on routine work and receives general instructions on new assignments
• May proactively recommend 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