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Advanced Bio-Logic Solutions Corp.posted 4 months ago
$54,080 - $62,400/Yr
Full-time - Entry Level
Holly Springs, NC
Administrative and Support Services

About the position

The position involves supporting the inspection, sampling, and testing of raw materials at the North Carolina site, ensuring compliance with cGMP manufacturing standards. The role requires leadership in scheduling, coordination, and training, with opportunities for professional growth through additional responsibilities and training.

Responsibilities

  • 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.
  • Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements.
  • Document inspection, sample, and test results accurately in Amgen's systems.
  • Assess characteristics that could potentially impact product quality according to procedures.
  • Determine if the color of components matches required attributes.
  • Support inspection readiness activities.
  • Support 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 ANC's raw material inspections, samples, and testing areas.
  • Provide QA oversight to Warehouse and ensure adherence to GMP regulations.

Requirements

  • High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelors degree.
  • Strong understanding of cGMP regulations and GDP requirements.
  • Experience with SAP, LIMS, and Track wise.
  • Experience with RAMAN technology, TruScan, and drafting and creating an SOP.
  • Experience in raw material inspections, sampling, and testing.
  • A minimum of 1+ years of relevant working experience required.

Benefits

  • Pay Rate- between $26 - $30/Hr. on W2 based on experience.
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