Lead Deviation & Investigation Writer - Aseptic Fill-Finish

Stark Pharma Solutions Inc; Midland (MI); On-site; USD 120,000 - 170,000; Full time

Job summary

Stark Pharma Solutions Inc. in Michigan seeks an experienced Deviation Writer/Investigation Writer to join our regulated manufacturing teams. The role centers on writing and investigating manufacturing deviations, with emphasis on aseptic fill-finish operations.

You will partner with QA, Manufacturing, Engineering, Validation, QC, and Operations to review records, perform root cause analysis, and develop CAPAs ensuring GMP compliance and quality system effectiveness.

Qualifications

• 10+ years in pharmaceutical/manufacturing environments with deviation investigations.
• Extensive experience writing complex deviation and investigation reports.
• Strong knowledge of GMP, FDA regulations, and pharmaceutical quality systems.
• Experience with RCA and CAPA development.
• Experience in aseptic fill-finish environments.

Responsibilities

• Support QA teams in reducing deviation and investigation backlogs.
• Lead and support investigations related to manufacturing deviations.
• Investigate deviations within aseptic fill-finish manufacturing environments.
• Review batch records, SOPs, equipment records, and quality data.
• Write GMP-compliant investigation reports with clear rationale.
• Develop CAPAs and assess their effectiveness.
• Collaborate with QA, Manufacturing, Engineering, Validation, QC, and Operations.
• Ensure investigation documentation meets GMP and internal quality requirements.
• Provide technical and scientific justification for investigation conclusions.
• Support investigation review meetings and timely deviation closure.

Skills

10+ years experience

Deviation writing

Investigation writing

Root Cause Analysis (RCA)

GMP knowledge

Regulatory knowledge

Technical writing

Cross-functional collaboration

Job description

Stark Pharma Solutions Inc. in Michigan seeks an experienced Deviation Writer/Investigation Writer to join our regulated manufacturing teams. The role centers on writing and investigating manufacturing deviations, with emphasis on aseptic fill-finish operations.

You will partner with QA, Manufacturing, Engineering, Validation, QC, and Operations to review records, perform root cause analysis, and develop CAPAs ensuring GMP compliance and quality system effectiveness.