Deviation Investigator | Rensselaer, New York | Onsite

Title: Deviation Investigator

Location: Rensselaer, New York | Onsite

Job Type- Contract

Duration: 6-12+ Months

Summary:

• Focus should be on candidates with deviation management experience in API manufacturing. Also, this comes directly from the Hiring Manager "we are looking for doers, strong communicators, not necessarily senior level, but individuals who will proactively gather information in person, write the investigations, and collect signatures for any needed extensions.

Important:

Client is looking for TWO separate resources:

• One candidate MUST have prior hands on experience in API Manufacturing environments
• One candidate MUST have prior hands on experience in Sterile Fill Finish Manufacturing environments

Role Overview

• Client is looking for experienced deviation investigators to support backlog investigation activities within GMP manufacturing environments. This is a hands on operational role, not a senior management or pure compliance/auditor position. The ideal candidate should have direct experience supporting investigations on the manufacturing floor and be comfortable working closely with Operations, QA and QC teams.

Main Responsibilities

• Lead deviation investigations from initiation to closure
• Perform root cause analysis using tools such as:

• 5 Why
• Fishbone
• 6M
• Cause & Effect Analysis

• Write clear and well documented investigation reports
• Support CAPA definition, implementation and effectiveness checks
• Support backlog investigation remediation activities
• Work closely with Manufacturing, QA, QC and technical teams during investigations
• Update SOPs and GMP documentation when required

Required Experience

• Previous hands on experience in: API Manufacturing OR Sterile Fill Finish Manufacturing
• Experience performing deviation investigations in GMP environments
• Shop floor manufacturing experience
• Strong root cause analysis and investigation skills
• Good technical writing/documentation skills
• Experience with CAPA activities
• Experience supporting manufacturing/process troubleshooting

Nice to Have

• Quality Operations experience
• QC chemistry lab experience
• Aseptic manufacturing experience
• Batch investigation experience
• Backlog investigation remediation experience

Interview Focus:

• Client is heavily focused on practical investigation experience.

Candidates should be able to explain:

• real investigation examples
• how they approach deviations
• practical use of RCA tools
• CAPA implementation
• investigation effectiveness evaluation
• examples from manufacturing/shop floor environments

Important Note

• Profiles focused mainly on CQV, utilities, validation, auditing or compliance without direct manufacturing investigation experience are less likely to fit the role.