Amneal Pharmaceuticals Jobs Hiring Now

• Follow work instructions, production specifications, and standard operating procedures (SOPs) to perform key responsibilities and maintain quality data while meeting production goals and timelines and minimizing downtime/delays. Work instructions include but are not limited to:
  • Weighing and dispensing of materials
  • Media and buffer preparation
  • Operation of filtration systems (such as dead-end filtration, depth filtration, tangential flow filtration)
  • Inoculation, fermentation, harvest, and homogenization of cytokine cells
  • Setup and operation of chromatography columns
  • Aseptic final filtration of intermediates and drug substances
  • Monitor product for quality output using PLC controls, HMI interfacing, integrity testing, and in process testing (pH, Conductivity, and Spectroscopy).
  • Properly handle and discard hazardous materials (i.e, buffers, chemicals, etc.) in accordance with EHS guidelines. Remove used and soiled materials from manufacturing areas.
  • Follow daily and weekly cleaning routines for cleanrooms and equipment to maintain the required conditions for cleanroom manufacturing.
  • Track, request, stage and verify raw materials and commodities; accurately enter raw material and commodities data in MES on daily basis
  • Completes Batch Records and other cGMP documentation accurately and in a timely manner in compliance with good documentation practices, including but not limited to ALCOA++.
• Revision of solution preparation batch records, SOPs, protocols, and logbooks
• Provides support during quality audits and regulatory inspections
• Reports nonconformances or events that arise during the shift to the Supervisor
• Complies with all safety, cGMP and Company policies, practices and procedures.
• Performs other functions as required or assigned

• Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred OR high school diploma and 1-2 years of industry experience required
Aseptic techniques and cleanroom manufacturing experience is preferred.

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• Ability to understand and adhere to written and verbal instructions
• Ability to understand technical information, procedures, batch records, and other documents in English.
• Ability to learn properly and efficiently using various hand and electrical tools.
• Ability to work in fast-paced environment and handle manufacturing demands and priorities. The schedule is driven by process requirements. The need for support of manufacturing activities may run through weekends or outside of normal shift hours.
• Excellent interpersonal skills, effective communication with peers and supervision.
• Reasoning Skills
  • The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
  • Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes
  • Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
  • Computer and/or Technical Skills
  • Basic computer skills, including Microsoft Word, Excel, and PowerPoint
  • Operation and understanding of data management software
  • Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
  • Knowledge of GMP, GDP and safety requirements.
  Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Mixing systems, Weigh Scales, etc.
  
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• General Work Environment: GMP Clean rooms and Laboratories
• Standing/Lifting :
  • Must be able to move around the facility to reach various equipment
  • Physical lifting and shift required for pushing and pulling containers. Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching.
  • Must be able to lift at least 25 lbs. Frequent moving of 25-50 lbs on carts.
  • Frequent moving of 100-250 lbs with assistance.
  Frequent repetitive motions.
  
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• Shift A (first shift): 06:00 AM to 2:30 PM CST,
• Shift B (first shift): 9:00 AM to 5:30 PM CST (first 14 days for training),
• Shift C (second shift): 2:00 PM to 10:30 PM CST,
• and Shift D (third shift): 10:00 PM to 6:30 AM CST.
• Overtime (time-and-a-half pay), holidays, and weekends will be required based on process requirements.
  

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

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 accommodations@amneal.com . Requests will be handled confidentially and in accordance with applicable laws.