“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
Day to Day Responsibilities:
- 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
"This posting is for Contingent Worker, not an FTE"
- 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