Production Lead 2nd Shift

Sharp Services•Bethlehem, PA

2d•Onsite

About The Position

This role is responsible for leading production activities, ensuring compliance with regulations, and managing personnel. The Production Lead will train staff, oversee packaging operations, maintain a compliant work environment, and contribute to process improvements and documentation.

Requirements

Knowledge of company SOPs
Knowledge of applicable OSHA regulations
Knowledge of cGMP regulations
Experience in packaging clinical supplies
Experience in reviewing executed packaging batch records
Experience in maintaining packaging areas
Experience in overseeing operation of packaging equipment
Experience in overseeing general housekeeping of packaging, labeling, assembly, and manufacturing areas
Experience in monitoring staffing utilization, operational flow of MIs, and equipment usage
Experience in maintaining, enforcing, and adhering to company policies
Experience in recruiting, hiring, training, timekeeping, appraising, and coaching team members
Experience in providing disciplinary action
Experience in reviewing and writing company SOPs
Experience in executing investigations, deviations, and customer complaints
Experience in monitoring non-job specific inventory and ordering

Responsibilities

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