Production Lead 2nd Shift

Sharp Corporation; Town of Bethlehem (NY); Sur place; USD 60 000 - 90 000; Plein temps

Résumé du poste

Sharp Packaging Services is seeking a packaging operations supervisor/lead to oversee the daily activities of packaging staff in a GMP-compliant facility in Bethlehem, NY. You will train personnel, schedule packaging, and ensure adherence to SOPs, cGMP, and OSHA requirements.

You will also review batch records, maintain packaging areas, oversee equipment, and participate in staffing, coaching, and investigations related to packaging operations.

Qualifications

• Knowledge of SOPs and cGMP requirements.
• Familiarity with OSHA regulations as they apply to packaging operations.
• Ability to operate and oversee packaging equipment in a compliant environment.

Responsabilités

• 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 packaging of clinical supplies per MIs and cGMP.
• Review batch records for compliance with cGMP and SOPs.
• Maintain packaging areas per SOPs and cGMP.

Connaissances

SOPs knowledge

cGMP regulations

OSHA regulations

Outils

Packaging equipment

Description du poste

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

About Sharp Packaging Services

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.