Quality Assurance Specialist

3 weeks ago


Conshohocken, Pennsylvania, United States Sharp Corporation Full time

Job Summary:

Sharp Corporation is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

Key Responsibilities:

  • Enforce GMP compliance throughout the facility, including gowning attire, personnel hygiene, and handling/storage of materials.
  • Review and verify packaging records, including documentation, room identification, equipment, and components.
  • Perform quality inspections, including visual, functional, destructive, and count checks, to ensure compliance with AQL requirements.
  • Verify equipment asset numbers, calibrated equipment, and component attributes against Work Order, CoA/CoC, and Component Receipt/Return Form.
  • Approve packaging records, including AQL Sampling Plan calculation and verification of label and pallet tag information.
  • Participate in continuous improvement projects and provide training to quality inspectors.

Requirements:

  • Associate's or Bachelor's degree in a related field or equivalent experience.
  • General knowledge of FDA regulations related to cGMP and quality control/assurance.
  • Good documentation and communication skills.
  • Ability to apply moderately complex mathematical operations to assigned tasks.

Working Environment:

The working environment is clean and not normally subject to hazardous environments or conditions. The employee is normally required to stand for long periods of time within a production room.



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