Manufacturing Operator

Aurobindo Pharma USA, Inc.Durham, NC
Onsite

About The Position

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 as well as Injectable 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 (Such as Injectable) 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. Manufacturing Operator is to perform all required Batch manufacturing, equipment cleaning, area cleaning, in- process testing & sampling for Manufacturing batches. Perform maintenance and troubleshooting of the equipment and machinery. Perform verifications using special instruments (Leak tester, Balance, etc.).

Requirements

  • Experience (minimum 1 year) with handling of Pharmaceutical manufacturing.
  • Experienced with operation & maintenance of pharmaceutical or any type of equipment/machinery.
  • Familiar with proper documentation and correction practices.
  • Knowledge of machine adjustments during set up, operation, troubleshooting, cleaning before & after use.
  • Knowledge of weights, scales & measures, experience of handling measuring equipment/instruments.
  • Must be a team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, Warehouse, Engineering and Supply Chain to meet goals.
  • Possess the ability to analyze information and make consistently good decisions.
  • A familiarity with cGMP, CFRs, OSHA and FDA regulations.
  • Knowledge of deviations/incidents and CAPA.
  • Be available for overtime, including weekends, as needed for production support
  • Possess the ability to analyze information and make consistently good decisions.

Responsibilities

  • Assist the Batch manufacturing, Packing & Cleaning of the equipment machinery and area.
  • Assist all required In-process testing & sampling of batches in progress and products to be packaged.
  • Assist Calibration of weighing and required equipment.
  • Perform packaging activities.
  • Handle various requests from departments for developmental or investigative reasons.
  • Complete all applicable training forms in a timely manner and forward to document control for archival.
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