Production Lead 1st Shift

The Production Lead, acting under minimal supervision, will develop and lead a cohesive multi-functional work team(s) to produce a quality product in a safe and efficient manner while adhering to all compliance standards.  He/she oversees all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly.  Directs and supports teams to execute clinical and commercial Productiones to meet production objectives in accordance with SOPs and cGMP requirements.

Essential Duties and Responsibilities

• Over sees Production Areas assigned by the Supervisor.
• Creates and reviews supporting documentation associated with the packaging operation(s) being performed. i.e., Batch Records, forms, etc.
• SME (Subject Matter Expert) in multiple areas.  Creates Four Phase Training documentation, Trains peers and subordinates, and shares job knowledge.
• SAP (Inventory Management Systems).
• Create and revise SOPs.
• Assist in quality-related investigations.
• Continuous Improvement Leader (Drive change through data metrics).
• Work with fellow Leads to allocate staff according to scheduled priorities.
• Operate, set-up, adjust packaging equipment.
• Perform system challenges, in Production inspections, and clinical start up activities.
• Ensure your area is in adherence to all safety standards outlined in governing SOPs.
• Ensure your areas is in adherence to all housekeeping standards outlined in governing SOPs.
• Monitor Material Replacement Order (MRO) supplies.
• Adhere to set safety standards.
• Participate actively in regular meetings.
• Achieve expected performance measures.
• Other duties as assigned by the Production Supervisor.