Production Lead 2nd Shift

Sharp Services•Bethlehem, PA

About The Position

The Production Lead supervises and oversees the packaging of clinical supplies according to approved MIs, company SOPs, and cGMP regulations. The role ensures packaging areas and equipment are operated and maintained in compliance with applicable procedures and safety regulations. It also supports training and oversight of production personnel, scheduling, staffing, documentation review, continuous improvement, and packaging-related investigations.

Responsibilities

Train Production personnel on company SOPs and applicable OSHA regulations.
Prepare daily schedules for packaging personnel.
Train Production Room Leaders on job-specific duties.
Supervise and oversee packaging of clinical supplies as determined by approved MIs and in accordance with company SOPs and cGMP regulations.
Review executed packaging batch records for compliance with cGMP regulations, company SOPs, and MIs.
Ensure packaging areas are maintained in accordance with company SOPs and cGMP regulations before, during, and after packaging operations.
Oversee packaging equipment operation to ensure compliance with company SOPs and applicable OSHA safety regulations.
Oversee housekeeping in packaging, labeling, assembly, and manufacturing areas.
Monitor staffing utilization, MI operational flow, and equipment usage, and recommend improvements to management.
Maintain, enforce, and adhere to company policies to provide security and a safe environment for personnel.
Assist with recruiting, hiring, training, timekeeping, appraising, and coaching team members, and provide disciplinary action as necessary.
Review and write company SOPs relating to the packaging area.
Assist with investigations, deviations, and customer complaints relating to the packaging area.
Monitor non-job-specific inventory and order as needed.