About The Position
The Group Leader leads the manufacturing process for batches and demonstrates the methods and procedures used to produce products with state-of-the-art processing systems, including sophisticated recipe-controlled human-machine interface (HMI) control systems. The role is responsible for verifying materials and documentation, coordinating production activities and personnel, and ensuring equipment, rooms, and processes meet applicable cGMP, safety, and company requirements.
Requirements
- High school diploma or GED.
- At least 3 years of manufacturing experience in the pharmaceutical or medical device industry.
Responsibilities
- Verify all product, packaging, and manufacturing components before operations begin and before materials enter the packaging room.
- Check products, ousters, and labels against specifications in the batch record, work order, and packaging record.
- Ensure accurate entries in logbooks and confirm batch documentation is complete.
- Initiate batch records according to the production schedule and verify staging status for upcoming batches on each line.
- Print and inspect shipper case labels for accuracy.
- Ensure 100% label reconciliation, verify results against the vision system report, and submit reviewed documentation to Quality Assurance promptly.
- Follow the manufacturing schedule based on the shipping forecast.
- Ensure manufacturing components are properly identified by status throughout the manufacturing and packaging process.
- Dispose of rejected material and packaging components according to established procedures.
- Verify equipment calibration status before use.
- Set up, operate, and clean equipment in compliance with cGMP standards.
- Complete ROSS transactions promptly and schedule personnel strategically to support efficient processes across manufacturing rooms.
- Follow Amneal Packaging CAPAs and Standard Operating Procedures (SOPs).
- Wear appropriate safety and protective gear and comply with dress code requirements.
- Maintain focus during manufacturing and packaging to prevent mix-ups and cross-contamination.
- Keep all rooms clean, organized, and compliant.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
