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Senior Visual Inspection Advisor

2 months ago

Massachusetts, United States GForce Life Sciences Full time

Position Overview

GForce Life Sciences is collaborating with a prominent 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 Summary

The Visual Inspection Subject Matter Expert (SME) will be pivotal in maintaining the integrity, compliance, and precision of visual inspection protocols in line with industry benchmarks and regulatory mandates. The consultant will be tasked with formulating and executing inspection criteria, training staff, and offering specialized knowledge in visual inspection techniques.

Core Responsibilities:

  • Perform comprehensive visual evaluations of pharmaceutical products to detect defects and deviations.
  • Investigate the underlying causes of AQL discrepancies and suggest practical solutions for corrective measures.
  • Establish and enforce visual inspection protocols tailored to medical devices and pharmaceutical items.
  • Educate and guide quality assurance teams on optimal visual inspection methodologies.
  • Engage with interdisciplinary teams, including production, quality assurance, and regulatory compliance, to ensure thorough resolution of quality challenges.
  • Compile findings, suggestions, and corrective measures in detailed documentation.
  • Provide continuous support and expertise to the quality assurance division throughout the engagement.
  • Deliver technical direction and training to staff involved in visual inspection tasks.
  • Ensure adherence to regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, USP790/1790) and internal quality benchmarks through systematic evaluations.
  • Assist in regulatory reviews and assessments related to visual inspection protocols.

Qualifications Required

  • 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 understanding of AQL standards and methodologies.
  • Demonstrated success in identifying and rectifying quality challenges in pharmaceutical products.
  • Proven expertise as a visual inspection SME within the pharmaceutical field.
  • Thorough knowledge of regulatory guidelines (e.g., FDA 21 CFR Part 820, ISO 13485, USP790/1790) and industry practices concerning visual inspection.
  • Established capability to create and implement visual inspection protocols in a regulated setting.
  • Exceptional analytical, problem-solving, and communication abilities.

Contract Details

Duration: 1 month with potential for extension

Work Schedule: Full-time (40 hours/week)