Deviations Investigator I

Renaissance Lakewood LLC; Lakewood Township (NJ); On-site; USD 76,000 - 81,000; Full time

Job summary

Renaissance Lakewood LLC in Lakewood, NJ seeks a QA Investigator to perform preliminary investigations, interview personnel, review supporting materials, and interpret test results. The role demands at least 3 years in life sciences within a cGMP environment and a BS in Life Science, with familiarity with TrackWise/LIMS/ERP.

Collaboration with Quality is key to identifying root causes and implementing corrective actions.

Qualifications

• 3+ years' experience in Life Sciences (pharma/devices) within a cGMP environment.
• Experience with investigation writing and root-cause analyses.
• Knowledge of internal systems (TrackWise, LIMS, ERP) preferred.

Responsibilities

• Perform preliminary investigation for assigned task.
• Interviews with relevant personnel.
• Review and interpret relevant test results or independent reports.
• Identify preliminary impact and collaborate with Quality 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 ratings as defined by area management.
• Prepare training materials and perform relevant training associated with assigned investigations.
• Complete Corrective Action assignments.
• Perform Corrective action or Preventative Action Effectiveness Checks.

Skills

Investigations

cGMP compliance

Technical writing

Education

Bachelor of Science in Life Science

Tools

TrackWise

LIMS

ERP

Job description

• 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.

Description

• 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.

Required

• 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 (TrackWise, 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
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.