Production Lead 2nd Shift

Sharp Services, LLC; Bethlehem, Northern (Northampton County, KY); Hybrid; USD 56,000 - 78,000; Full time

Job summary

Sharp Packaging Services seeks a dedicated supervisor to oversee packaging of clinical supplies and enforce cGMP and SOP compliance across the production floor.

The role includes training personnel on company SOPs and OSHA regulations, scheduling, reviewing batch records, and maintaining safe, organized packaging areas and equipment.

Responsibilities

• Train Production personnel on SOPs and OSHA regulations.
• Prepare daily scheduling of packaging personnel.
• Supervise packaging of clinical supplies per MIs and cGMP.
• Review batch records for compliance with cGMP and SOPs.
• Oversee packaging areas and equipment; ensure safety and housekeeping.

Job description

Essential Duties and 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.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry.

We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products.

Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery.

Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.