Deviations Investigator

• Pay or shift range: $75,600 USD to $81,300 USD
• The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

• Perform preliminary investigation for assigned task.
• Perform interviews with relevant personnel.
• Perform document or supporting material review.
• Review and interpret relevant test results or independent reports.
• Identify preliminary impact.
• Collaborate with Quality counterparts to triage nonconformance events.
• Assign root cause and final impact.
• Provide commitment dates for assigned tasks.
• Assess root cause and provide recommendation for corrective and/or preventative action.
• Maintain performance rating as defined by area management.
• Prepare training material and perform relevant training associated with assigned investigations.
• Complete Corrective Action assignments.
• Perform Corrective action or Preventative Action Effectiveness Checks.

• Can provide accurate commitments for completion of assigned work based on one’s bandwidth and escape challenges accordingly.
• Must be compliant to cGMPs and site procedures.
• Must comply with site safety procedures while on campus.
• Maintain personal training compliance.
• Must take initiative and perform required steps of an investigation(s) in a timely manner.
• Must have or obtain knowledge of internal systems necessary to perform a comprehensive investigation (Track Wise, LIMS, ERP, etc.).
• Must obtain reasonable technical understanding of process, equipment, and/or systems to adequately investigate events and effectively articulate sound rationale for root cause and impact of such events.
• Minimum of 3 years of relevant experience in Life Sciences especially in Pharmaceuticals/Medical Device in a cGMP environment
• Bachelor of Science in Life Science / related discipline preferred
• Technical/Investigation writing experience preferred

Equal Opportunity Employer
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For further information, please review the Know Your Rights notice from the Department of Labor.