Manufacturing Product & Packaging Group Lead - Day Shift

Amneal Pharmaceuticals LLC (J0P); Piscataway Township (NJ); On-site; USD 70,000 - 95,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Group Leader to oversee the manufacturing process for batches, using state-of-the-art HMI control systems. The candidate will ensure data integrity, labeling accuracy, calibration, and adherence to cGMP standards.

Responsibilities include initiating batch records, verifying components, scheduling personnel, and ensuring clean, compliant production rooms. High school or GED and 3+ years in pharmaceutical manufacturing are required.

Qualifications

• 3+ years of manufacturing experience in the Pharmaceuticals or Medical Device industry.
• Must adhere to cGMP standards and maintain accurate documentation.

Responsibilities

• Verify all product and packaging components against batch records and labels.
• Initiate batch records per production schedule and ensure labeling accuracy.
• Adhere to manufacturing schedule and manage disposal of rejected materials per procedures.
• Verify equipment calibration status and perform setup, operation and cleaning per SOPs.
• Follow Amneal Packaging CAPAs and SOPs; wear safety gear and maintain clean rooms.

Skills

Batch manufacturing

cGMP compliance

Documentation

Data entry

Equipment coordination

Education

High School or GED

Tools

HMI control systems

Vision system

Calibration procedures

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.