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Quality Assurance Senior Associate

West Greenwich, RI
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and  puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills                                                                            
  • Strong understanding of cGMP regulations and GDP requirements
  • Strong written and verbal communication skills
  • Experience in raw material inspections, sampling, and testing
  • Bachelor’s degree and 2 years of cGMP inspecting and/or sampling experience

Day to Day Responsibilities:                                
  • Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met.   This requires unpacking/packing and movement of boxes throughout the daily tasks.
  • Collect samples from a statistical number of containers for all chemicals to facilitate the testing of samples.  This activity requires gowning into a controlled room and standing/repetitive movements for large container opening and sampling of raw materials. 
  • Use RAMAN technology with TruScan and NIR equipment to identify chemicals
  • Ensure that inspection & sampling results are complete and detailed according to written procedures, specifications and cGMP requirements
  • Responsible for accurately documenting inspection, sample, and test results in Amgen’s systems
  • Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
  • Ability to determine the color of raw materials match required attributes
  • Support inspection readiness activities including site audits and inspections
  • Maintains project plan commitments supporting critical projects
  • Support Continual Improvement initiatives, programs and projects
  • Own controlled documents for the area including SOPs and FORMs
  • Initiate and own deviation records and CAPAs associated with events and projects in ARI’s raw material inspections, samples, and testing areas

"This posting is for Contingent Worker, not an FTE"

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