Manufacturing Product & Packaging Group Lead - 3rd Shift

Role Summary

The Group Leader is responsible for leading the manufacturing process of batches and demonstrating the methods to produce products using advanced processing systems, including recipe-controlled HMI control systems. This role follows a 12-hour rotating schedule, from 6:00 PM to 6:30 AM.

Responsibilities

• Verify all product and packaging/manufacturing components prior to start of operations and entry into the packaging room; confirm product, ousters, and labels against batch specifications; ensure accurate data entry in logbooks and complete documentation for each batch.
• Initiate the batch record per production schedule; verify staging status of upcoming batches; print and inspect shipper case labels; ensure 100% label reconciliation; verify results with the vision system report and submit reviewed documentation to Quality Assurance in a timely manner.
• Adhere to the manufacturing schedule based on shipping forecast; ensure proper status identification of components in manufacturing/packaging rooms; dispose of rejected material and packaging components per established procedures.
• Verify calibration status of all equipment before use; perform equipment setup, operation, and cleaning in compliance with cGMP standards; complete all ROSS transactions and strategically schedule personnel to ensure efficient processes across manufacturing rooms.
• Adhere to packaging CAPAs and SOPs; wear appropriate safety and protective gear and comply with dress code requirements.
• Maintain focus to prevent mix-ups and cross-contamination; keep rooms clean, organized, and compliant at all times.

Education

• High School or GED - Required

Experience

• 3 years or more of Manufacturing experience within Pharmaceutical or Medical Device industry

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 understanding terminology of the job - Advanced
• Ability to comprehend and follow written and verbal procedures or instructions - Advanced
• Math and mechanical skills - Advanced
• Safety compliance and reinforcement - Advanced
• Attention to detail - Advanced

Additional Requirements

• Flexible to work extended hours when required
• This position requires successful completion of an OSHA-compliant Respirator Fit Test