Quality Assurance Visual Inspection Specialist

2 weeks ago


Massachusetts, United States GForce Life Sciences Full time

Position Overview

GForce Life Sciences is collaborating with a leading Fortune 500 Medical Device Company to recruit a Visual Inspection Consultant. This role is essential for addressing and mitigating AQL (Acceptable Quality Level) discrepancies.

Role Responsibilities

The Visual Inspection Subject Matter Expert (SME) will be instrumental in upholding the quality, compliance, and precision of visual inspection processes in line with industry benchmarks and regulatory standards. Key responsibilities include:

  • Performing comprehensive visual evaluations of pharmaceutical products to detect defects and deviations.
  • Investigating the underlying causes of AQL failures and proposing effective corrective measures.
  • Establishing and enforcing visual inspection protocols tailored to medical devices and pharmaceutical items.
  • Providing training and guidance to quality assurance teams on optimal visual inspection techniques.
  • Working collaboratively with various departments, including manufacturing, quality control, and regulatory affairs, to ensure thorough resolution of quality challenges.
  • Documenting observations, suggestions, and corrective actions in detailed reports.
  • Offering continuous support and expertise to the quality assurance team throughout the engagement.
  • Delivering technical training to staff involved in visual inspection processes.
  • Ensuring adherence to regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, USP790/1790) and internal quality benchmarks through regular audits and evaluations.
  • Assisting in regulatory inspections and audits concerning visual inspection practices.

Qualifications Required

  • A Bachelor's degree in a relevant discipline (e.g., Pharmaceutical Sciences, Engineering, Quality Assurance).
  • A minimum of 10 years of experience in visual inspection within the pharmaceutical sector.
  • Extensive knowledge of AQL standards and methodologies.
  • A proven history of identifying and rectifying quality issues in pharmaceutical products.
  • Demonstrated experience as a visual inspection SME in the pharmaceutical field.
  • Thorough understanding of regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, USP790/1790) and industry standards pertinent to visual inspection.
  • Proven capability to create and implement visual inspection protocols in a regulated setting.
  • Strong analytical, problem-solving, and communication abilities.

Engagement Details

Duration: 1 month with potential for extension as necessary.

Work Arrangement: Full-time (40 hours/week), onsite.



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