Deviations Investigator I

Renaissance-Lakewood,-LL; Lakewood Township (NJ); Sur place; USD 76 000 - 81 000; Plein temps

Résumé du poste

Renaissance-Lakewood,-LL in Lakewood, NJ seeks a Life Sciences Investigator to perform preliminary investigations, interview personnel, review docs and test results, and identify root causes for corrective actions. You will collaborate with Quality to triage nonconformances and provide commitment dates while maintaining performance ratings.

The role requires a BS in Life Science and 3+ years in a cGMP environment, with experience in TrackWise, LIMS, ERP, and strong investigative writing skills.

Qualifications

• Must take initiative and perform required steps of an investigations timely.
• Knowledge of internal systems TrackWise, LIMS, ERP is required.
• Minimum 3 years of Life Sciences experience in cGMP environments.

Responsabilités

• Perform preliminary investigation for assigned task.
• Conduct interviews with relevant personnel.
• Review documents or supporting materials.
• Review and interpret test results or independent reports.
• Identify preliminary impact and triage nonconformance events.
• Assign root cause and final impact.
• Provide commitment dates for tasks.
• Assess root cause and recommend corrective/preventive actions.
• Maintain performance rating as defined by area management.
• Prepare training material and deliver related training.
• Complete Corrective Action assignments and CAPA checks.

Connaissances

Investigation execution

Root cause analysis

cGMP compliance

Formation

Bachelor of Science in Life Science

Outils

TrackWise

LIMS

ERP

Description du poste

Lakewood - 1200 Paco
1200 Paco Way
Lakewood, NJ 08701, USA

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  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

Licenses & Certifications

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.