Quality Assurance Technician

Location: Cleveland, OH
Department: Azzur Solutions, LLC

Job Description

Minimum Requirements:

  • 0-2 years experience in Quality Assurance is required
  • GMP and GDP experience in a regulated environment
  • OTC capacity experience
  • SAP experience preferred
  • ETW experience preferred

 

Essential Duties and Responsibilities:

  • Inspects shipments, reconciles labels, reviews and releases finished product and other paperwork.
  • Reviews QC testing documentation and results for conformance.
  • Confirms expiration dating and issues Certificates of Analysis for each lot.
  • Reviews and approves/rejects other various quality-related documents.
  • Assists in planning, developing, and implementing quality assurance programs.
  • Responds to customer requests, including but not limited to investigating complaints and completing required paperwork for corrective and preventive actions and associated follow-up.
  • Assists in changing and maintaining ISO and cGMP paperwork. Trains or overseas training.
  • Ensures the quality requirements of all departments are being followed and are accurately documented.
  • Complete PM/Calibration documentation files and manages Out of Service Equipment.
  • Oversees to assure Validations are performed according to approved protocols and samples provided as requested.
  • Interprets, understands, and manages a variety of technical information.
  • Prepares routine, technical, and special presentations/reports to staff and management as required.
  • Oversees the writing and maintaining of owners process manuals.
  • Coordinate and perform quality assurance system internal audits, investigate non-conformances, and determine root cause analyses.
  • Reviews the current policies determining and documenting any areas that may need quality improvements.
  • Perform other duties as assigned.


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