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API Manufacturing Facility
Job Location:
Job Location:
Rensselaer, NY - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
3 June 2026 (30+ days ago)
Posted:
Application Deadline:
31 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
API Manufacturing Facility
Rensselaer NY
4 Months Contract
Rensselaer NY
4 Months Contract
Important Note
Profiles focused mainly on CQV utilities validation auditing or compliance without direct manufacturing investigation experience are less likely to fit the role.
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:
o 5 Why
o Fishbone
o 6M
o 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
Lead deviation investigations from initiation to closure
Perform root cause analysis using tools such as:
o 5 Why
o Fishbone
o 6M
o 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
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
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.
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
real investigation examples
how they approach deviations
practical use of RCA tools
CAPA implementation
investigation effectiveness evaluation
examples from manufacturing/shop floor environments
