The role will support the inspection, sampling, and testing of raw materials that are received at the North Carolina (ANC) site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.
Primary Responsibilities of the Role Include:
Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
Remove samples from containers of medias and other chemicals to facilitate the testing of samples
Use RAMAN technology with TruScan equipment to identify chemicals (must have)
Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements
Responsible for accurately documenting inspection, sample, and test results in systems
Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
Ability to determine the color of components match required attributes
Support inspection readiness activities
Supports Continual Improvement initiatives, programs and projects
Assist area management with the prioritization and scheduling of tasks
Serve as a trainer in tasks associated with raw material inspections, samples, and testing
Own controlled documents for the area including SOPs and FORMs
Initiate and own deviation records and CAPAs associated with events and projects in ANCs raw material inspections, samples, and testing areas
Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.
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