Demo

Deviation/Investigation Specialist

ILabz Technology
Richmond, VA Full Time
POSTED ON 2/7/2025
AVAILABLE BEFORE 4/7/2025

Roles and Responsibilities:

· Oversee the deviation process from initiation to closure, ensuring all discrepancies from standard operating procedures, specifications, or regulations are captured, investigated, and documented.

· Coordinate and lead detailed investigations of product deviations, identifying root causes and evaluating their impact on product quality, safety, and regulatory compliance.

· Work with teams across departments (e.g., Quality Assurance, Manufacturing, R&D, Regulatory Affairs) to gather data, conduct investigations, and identify process improvements.

· Guide investigation teams in performing detailed root cause analyses using methodologies like the 5 Whys, Fishbone Diagrams, and Failure Modes and Effects Analysis (FMEA).

· Analyze the potential impact of deviations on product quality, customer safety, regulatory compliance, and business operations. Assess whether deviations are isolated or affect multiple batches or products.

· Oversee the creation and implementation of CAPA plans to address root causes and prevent recurrence.

· Ensure CAPA plans are properly designed, implemented, and evaluated for sustained improvements. Verify the resolution of issues and effectiveness of actions.

· Maintain thorough documentation of product deviations, including investigation findings, root cause analyses, CAPA actions, and follow-up activities, in compliance with company and regulatory policies.

Strong knowledge of Good Manufacturing Practices (GMP), ISO standards, and relevant regulatory requirements (e.g., FDA 21 CFR Part 820 for medical devices).

Job Type: Full-time

Pay: $40.00 - $45.00 per hour

Expected hours: 40 per week

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible schedule
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift

Experience:

  • Deviation/Investigation Specialist: 6 years (Required)
  • Manufacturing: 6 years (Required)
  • GMP: 6 years (Required)

Work Location: On the road

Salary : $40 - $45

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