Genovice

This is a remote position.

GMP Manufacturing Deviation Investigator
Position Overview

Our client, a growing pharmaceutical manufacturing organization in Indianapolis, is seeking an experienced GMP Manufacturing Deviation Investigator to support ongoing manufacturing and quality activities.

This is a hands-on consulting role for someone who can take ownership of deviations, work directly with technical teams to understand what occurred, identify root cause and impact, and drive investigations through compliant and timely closure.

Key Responsibilities

• Independently lead and author GMP deviation investigations through closure.
  
• Investigate issues related to manufacturing operations, processes, equipment, facilities, and other GMP activities.
  
• Gather and evaluate information from batch records, equipment documentation, system records, test results, and other supporting evidence.
  
• Work closely with Manufacturing, Quality, Engineering, Validation, and other technical SMEs during investigations.
  
• Conduct root cause analysis (RCA) and document clear, supportable conclusions.
  
• Assess potential product, process, equipment, and quality impact associated with deviations.
  
• Identify and support appropriate CAPAs based on investigation findings.
  
• Ensure investigation reports are clear, technically accurate, and inspection ready.
  
• Support investigation backlog reduction and other quality/remediation activities as needed.
  
• Assist with updates to SOPs, change controls, forms, and other GMP documentation when investigation findings require changes.
  
• Support audit and inspection-readiness activities as needed.
  

Qualifications

• 6+ years of hands-on deviation investigation experience within pharmaceutical, biotech, biopharmaceutical, or another GMP manufacturing environment.
  
• Demonstrated ability to independently investigate, author, and close GMP deviations.
  
• Strong experience with root cause analysis and CAPA.
  
• Strong technical writing and documentation skills.
  
• Ability to review and interpret manufacturing and technical documentation as part of an investigation.
  
• Experience with manufacturing, equipment, engineering, facilities, validation, or quality-related investigations preferred.
  
• Sterile, aseptic, injectable, biologics, or radiopharmaceutical experience is a plus.
  
• Comfortable working directly with cross-functional technical teams.
  
• Able to manage multiple investigations and priorities with minimal supervision.
  
• Experience working in GMP manufacturing and/or cleanroom environments preferred.
  
• Ability to provide hybrid/on-site support in Indianapolis, Indiana.
  

Ideal Candidate

The ideal candidate is a hands-on investigator, not someone whose experience is limited to reviewing or approving other people's deviations. They should be comfortable digging into the details of an event, interviewing SMEs, reviewing supporting records, determining root cause and impact, and writing a clear investigation that can withstand Quality and regulatory scrutiny.