Manufacturing Product & Packaging Group Lead - Shift D

Role Summary

Manufacturing Product & Packaging Group Lead - Shift D. The Group Leader is responsible for leading the manufacturing process of batches, demonstrating methods and procedures to produce products using state-of-the-art processing systems, including recipe-controlled HMI control systems.

Responsibilities

• Verify all product and packaging/manufacturing components prior to the start of operations and entry into the packaging room.
• Check and confirm the product, ousters, and labels against the product specifications outlined in the batch record, work order, and packaging record.
• Ensure accurate data entry in all logbooks and confirm the completion of documentation for each batch.
• Initiate the batch record according to the production schedule and verify the staging status of the upcoming batch for each line.
• Print and inspect shipper case labels to ensure accuracy.
• Ensure 100% label reconciliation, verify results with the vision system report, and submit all reviewed documentation to Quality Assurance in a timely manner.
• Adhere to the manufacturing schedule based on the shipping forecast.
• Ensure proper status identification of manufacturing components in the manufacturing/packaging rooms throughout the process.
• Responsible for the disposal of rejected material and packaging components in accordance with established procedures.
• Verify the calibration status of all equipment before use. Perform equipment setup, operation, and cleaning in compliance with cGMP standards.
• Promptly complete all ROSS transactions and strategically schedule personnel to ensure an efficient process across the manufacturing rooms.
• Must adhere to Amneal Packaging CAPAs and Standard Operating Procedures (SOPs).
• Maintain focus throughout the manufacturing/packaging process to prevent mix-ups and cross-contamination.
• Ensure all rooms remain clean, organized, and compliant at all times.

Qualifications

• Education: High School or GED - Required
• Experience: 3+ years of experience in Pharmaceutical or Medical Device Manufacturing - Required

Skills

• Good communication and interpersonal skills - Advanced
• Team coordination in a fast-paced manufacturing setting - Advanced
• Ability to read, write, and communicate in English at a level to facilitate the understanding terminology of the job - Advanced
• Ability to comprehend and follow written and verbal procedures or instructions - Advanced
• Have basic math and mechanical skills - Advanced
• Safety compliance and reinforcement - Advanced
• Attention to detail - Advanced

Additional Requirements

• Others duties as assigned.
• Always wear appropriate safety and protective gear and comply with the designated dress code requirements.