Amneal Pharmaceuticals LLC (J0P)

Description: The Scientist-2 is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods and maintains/qualifies analytical equipment. Essential Functions: Performs analysis and release of active pharmaceutical ingredients, excipients, in-process materials, and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs. Develops and optimizes new and existing analytical methods for qualification and release testing of products. Develops stability indicating methods and performs methods validation. Provides timely responses to all internal and external inquiries. Ensures...

Description: The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run. Essential Functions: Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures.  Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab.  Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine...

Description: The Automation Engineer is responsible for overseeing and optimizing automation systems to improve production efficiency and reduce operational costs. This position involves designing, integrating, and implementing advanced hardware and software solutions within pharmaceutical manufacturing facilities. Essential Functions: Develop Control Systems based on coordination with OEM, in order to automate upstream and downstream processing equipment, including Mixers, Coaters, Pouchers, Cartoners, Packaging Lines, Laboratory equipment, facility systems, stability Chambers, BMS, CIP (Clean in Place) and SIP (Steam in Place), Water System Controls, Tablet Press, Fluid Bed Dryers, Granulators, Vision System etc. Perform programming, qualification and validation of digital process automation systems. Provide 24x7 on-call Automation Support, including technical support and troubleshooting functions. Perform formal systems acceptance testing, including...

Description: The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. Essential Functions: Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor Performs re-qualification of equipment, facility and utilities as required under supervision Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution Draft Standard Operating Procedure(SOP) for new operational equipment Supports process validation and cleaning validation by providing product contact surface area, equipment...

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.  This role follows a 12-hour rotating schedule, working from 6:00 PM to 6:30 AM. 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...

Description: The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run. Essential Functions: Perform inspection, sampling, and testing of incoming raw materials, packaging components, and returned goods per written procedures. Prepare samples for chemical and microbiological analysis and deliver them to the QC lab. Inspect and test packaging components using measuring devices (e.g., scales, micrometers, height gauges) to ensure specification compliance. Maintain detailed records of all sampling, inspection,...

Description: To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run. Schedule: 1st Shift 7:00am - 3:30pm Monday to Friday Essential Functions: Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures.  Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers...

Description: The Senior Training Specialist plays a vital role in fostering a culture of learning and compliance at Amneal. This position ensures the accuracy and security of training records while driving the development of effective training programs that empower employees and contractors to succeed. Working closely with cross-functional teams, the Senior Training Specialist helps translate regulatory requirements into practical, engaging learning experiences. Beyond maintaining curricula and supporting audits, this role is about inspiring confidence, building knowledge, and strengthening quality standards across the organization. As a key contributor to Amneal’s mission, the Senior Training Specialist not only supports compliance but also champions professional growth, making training a meaningful part of every employee’s journey. Schedule: 1st Shift 9am - 5:30pm Monday to Friday Essential Functions Evaluate change controls, CAPAs, and investigations to...

Description: Entry-level role within the Pharmacy Department responsible for dispensing ingredients for mixing and granulation. Works under close supervision and required to know SOPs and cGMP. Essential Functions: Responsible for accurately dispensing all materials as per batch record. Records and maintains the production batch records after each batch. Reviews and follows the batch records with 100% accuracy. Responsible for the pharmacy room to be clean, organized and ready for production. Responsible for maintain inventory and reconciliation of materials. Ensures the cleanliness and checks calibration status of all scales, and balances. Additional Responsibilities: Other duties as management assigns.   Education: High School or GED General HS Curriculum - Preferred Experience: less than one year in Pharmaceuticals manufacturing experience Skills: Required to read,...

Description: The Senior Training Specialist plays a vital role in fostering a culture of learning and compliance at Amneal. This position ensures the accuracy and security of training records while driving the development of effective training programs that empower employees and contractors to succeed. Working closely with cross-functional teams, the Senior Training Specialist helps translate regulatory requirements into practical, engaging learning experiences. Beyond maintaining curricula and supporting audits, this role is about inspiring confidence, building knowledge, and strengthening quality standards across the organization. As a key contributor to Amneal’s mission, the Senior Training Specialist not only supports compliance but also champions professional growth, making training a meaningful part of every employee’s journey. Essential Functions: · Evaluate change controls, CAPAs, and investigations to identify training needs. · Develop training plans for...

Description: The Packaging Operator II is responsible for safely operating the packaging equipment to package in process products in accordance with the Packaging Order while following SOPs and Maintaining 100% cGMP & compliance during operations. Schedule: 2nd Shift - 3:30pm - 12:00am Monday to Friday   Essential Functions: Checks and verifies product/outserts/label as per product specification in the batch record, work order and packaging records. Checks proper setting and operation of all the packaging equipment located in the packaging rooms. Responsible for ensuring the packaging line/room is clean, organized and ready for packaging operations. Performs packaging batch record documentation. Perform in-process checks during packaging operation and record the data in packaging batch record. Checks calibration status of all scales, balance and equipment. Responsible for disposal of rejected...

Description: Purified Water Technicians are responsible to maintain all of the facility purified water systems in good working condition. Including adding and adjusting chemical levels, making online adjustments, verifying that the system in general is producing water within current USP specifications & recording and filling the critical parameters of the plant. Maintaining the GMP documents. Schedule: 2nd Shift 3:30pm - 12:00am Tuesday to Saturday Essential Functions: Day to day Operation & Maintenance of all purified water Generation, storage and Distribution system of the plant. Support micro department for water sampling as & when require. Replenishes chemicals into auto dosing tanks as needed adjust chemical levels removes and cleans chemical holding tanks every 72 hours Mop the floor of the room everyday. Clean and wipe down the entire system every day Prepares chemicals: (anti-scaling, SMBS, & NAOH);...