“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"