Aurobindo Pharma USA, Inc. logo

Manufacturing Operator

Aurobindo Pharma USA, Inc.

  • Durham, North Carolina
  • 3 days ago
    Aurobindo Pharma USA, Inc.
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    Skills

    • Analysis Skillsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Calibrationunmatched
    • Check Processingunmatched
    • Cleaning Equipmentunmatched
    • Communication Skillsunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Depth Perceptionunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Drug Developmentunmatched
    • Equal Employment Opportunity (EEO)unmatched
    • Equipment Maintenance/Repairunmatched
    • FDA Requirementsunmatched
    • Facilities Engineeringunmatched
    • Geneticsunmatched
    • Health Economicsunmatched
    • High School Diplomaunmatched
    • Identify Issuesunmatched
    • Lift/Move 50 Poundsunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Equipmentunmatched
    • Manufacturing Operationsunmatched
    • Metered Dose Inhalersunmatched
    • OSHAunmatched
    • Physical Demandsunmatched
    • Procedure Developmentunmatched
    • Product Developmentunmatched
    • Product Packagingunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Metricsunmatched
    • Regulationsunmatched
    • Research & Development (R&D)unmatched
    • Riskunmatched
    • Safety Processunmatched
    • Safety Standardsunmatched
    • Safety Trainingunmatched
    • Standard Operating Procedures (SOP)unmatched
    • State Laws and Regulationsunmatched
    • Team Lead/Managerunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Warehousingunmatched

    Description

    Division Overview:

    Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing.  Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena.  The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly.  The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs.  In addition to several formulations under manufacture, we have a robust pipeline of products.  Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

    Job Overview:

    The Manufacturing Operator is responsible for executing all activities related to batch manufacturing and packaging in accordance with established procedures, safety requirements, and quality standards. This includes operating and cleaning equipment, conducting in‑process testing and sampling, performing dispensing activities, supporting calibrations, and troubleshooting machinery as needed. The operator also performs verifications using specialized instruments such as calipers and balances to ensure compliance with product specifications.

    Responsibilities:

    Manufacturing & Packaging

    • Perform batch manufacturing operations according to approved batch records, SOPs, and safety standards.
    • Execute pharmaceutical processing (filling, coating, cutting, etc) and packaging processes.
    • Verification of dispensed raw / packaging materials as required.
    • Conduct in‑process checks and sampling during manufacturing and packaging stages.

    Equipment Cleaning & Maintenance

    • Clean and sanitize equipment, tools, and production areas as per Standard Operating Procedures / Protocols.
    • Assist with basic maintenance, calibration, and verification activities for production equipment.
    • Troubleshoot equipment issues and escalate when needed to minimize downtime.

    Quality & Compliance

    • Complete all required forms, logs, and documentation accurately and in a timely manner.
    • Follow all SOPs, GMP guidelines, and safety procedures.
    • Support departmental requests related to developmental, investigative, or quality‑related activities.

    Additional Duties

    • Perform packaging and labeling activities as assigned.
    • Operate various production equipment safely and efficiently.
    • Assist in training new operators when required.
    • Perform other duties as assigned by management.
    • Make self availability for the cGMP / Hands-On / Classroom trainings and complete all applicable training forms in a timely manner.
    • Troubleshooting the manufacturing equipment operational issues as needed.
    •  

     

    Qualifications - Skills & Requirements:
    • Ability to follow detailed written procedures and documentation requirements.
    • Basic understanding of mechanical equipment and troubleshooting.
    • Strong attention to detail and commitment to quality.
    • Ability to work independently and within a team environment.
    • Familiarity with measurement tools (balances, calipers, etc.) preferred.
    • Be able to effectively communicate with Production team mates, Supervisor and cross functional team including Quality Assurance, Quality Control, Warehouse and Facilities & Engineering.
    • Possess the ability to analyze information and make consistently good decisions

     

    Education & Experience:
    • High school diploma or equivalent / higher required.
    • Should have wok experience of equipment operation, product changeovers, cleaning and basic operational troubleshooting for at-least 1 – 2 years in Pharmaceutical / Nutraceutical Production (manufacturing and/or packaging).

    (Experience in Metered dose inhaler (Metered Dose Inhalers (Inhalation) or Derma (Topicals) production would be preferred).

    • Familiar with Good documentation and correction practices.
    • Should have handful experience of GMP document record execution like batch records, logbooks, protocols, etc.
    • Knowledge of deviations/incidents and CAPA.
    • A familiarity with cGMPS, CFRs, OSHA and FDA regulations
    Physical Requirements: WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Additional Physical Requirements:
    Standing 4-8 HoursSitting 1-4 HoursWalking 1-4 Hours
    Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment. We Are An Equal Opportunity Employer: Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

    Numbers & Facts

    LocationDurham, North Carolina
    IndustryBiotechnology/Pharmaceuticals
    Company Size1,000 to 1,499 employees
    Websitehttps://www.aurobindousa.com/

    About Company

    Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992.

    Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients.  Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes.  Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. 

    Aurobindo markets over 80% of the top 100 most prescribed products in the world.  In past years, Aurobindo has received more ANDA approvals than any of our competitors.  Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010)

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