Manufacturing Product & Packaging Group Lead - Day Shift

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Piscataway, NJ, is seeking a Group Leader to oversee the manufacturing process of batches using state-of-the-art processing systems, including recipe-controlled HMI controls.

You will verify components, initiate batch records, ensure labels and documentation accuracy, and maintain compliance with cGMP in a fast-paced pharmaceutical environment. This role requires 3+ years of manufacturing experience in pharma or medical devices and a high school diploma or GED.

Qualifications

• High School diploma or GED is required.
• 3+ years of manufacturing experience in the pharmaceutical or medical device industry.

Responsibilities

• Verify all product and packaging/manufacturing components prior to operation and entry into the packaging room; confirm against batch records, work orders and packaging records; ensure accurate data entry and complete documentation for each batch.
• Initiate batch records per production schedule; verify staging status; print and inspect shipper labels for accuracy; ensure 100% label reconciliation and submit reviewed documentation to Quality Assurance.
• Adhere to the manufacturing schedule based on the shipping forecast; identify proper status of components in manufacturing/packaging rooms; dispose of rejected materials per procedures.
• Verify calibration status of all equipment before use; perform setup, operation and cleaning per cGMP; complete ROSS transactions and schedule personnel for efficient processing.
• Comply with Amneal Packaging CAPAs and SOPs; wear safety gear and follow dress code.
• Maintain clean, organized, and compliant manufacturing/packaging rooms to prevent mix-ups and cross-contamination.
• Other duties as assigned.

Education

High School diploma or GED

Job description

Description

The Group Leader is responsible for leading the manufacturing process of batches. In addition, the Group Leader will perform and demonstrate the actual methods and procedures to produce the products utilizing state of the art processing systems. These systems include sophisticated recipe-controlled human machine interface (HMI) control systems.

Essential Functions:

• 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). Always wear appropriate safety and protective gear and comply with the designated dress code requirements.

• 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.

Additional Responsibilities:

• Others duties as assigned.

Education:

• High School or GED - Required

Experience:

• 3 years or more in Manufacturing experience in the Pharmaceutical or Medical Device industry

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.