Deviation Writer

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Deviation Writer

Michigan

Long Term

We are seeking an experienced Deviation Writer / Investigation Writer with 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing environments. The ideal candidate will have strong hands-on experience writing and investigating manufacturing deviations, particularly within aseptic fill-finish operations
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• 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, environmental monitoring data, and quality documentation.
• Write clear, concise, technically sound, and GMP-compliant investigation reports.
• Perform root cause analysis using appropriate investigation methodologies.
• Identify root causes, contributing causes, and potential causes.
• Develop evidence-based investigation conclusions with clear technical rationale.
• Develop and support CAPA plans aligned with identified root causes.
• Evaluate the effectiveness of proposed CAPAs and quality controls.
• Investigate complex, recurring, and high-impact deviations.
• Conduct interviews with SMEs and personnel involved in quality events.
• Review historical deviations, batch history, equipment history, and quality trends.
• Identify recurring trends and potential systemic quality issues.
• Perform product, process, equipment, and impact assessments as required.
• Collaborate with QA, Manufacturing, Engineering, Validation, QC, and Operations teams.
• 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.

• 10+ years of experience in pharmaceutical, biopharmaceutical, or regulated manufacturing environments.
• 10+ years of deviation/investigation writing experience
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• Strong experience investigating manufacturing-related deviations in aseptic fill-finish environments
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• Strong knowledge of GMP, FDA regulations, and pharmaceutical quality systems.
• Extensive experience writing and reviewing complex deviation and investigation reports.
• Strong experience with Root Cause Analysis (RCA) and investigation methodologies.
• Proven experience developing CAPAs aligned with identified root causes.
• Strong technical writing and documentation skills.
• Ability to analyze complex information and develop clear, evidence-based conclusions.
• Experience working with cross-functional teams in regulated manufacturing environments.
• Strong attention to detail and problem-solving skills.
• Ability to manage multiple investigations and competing priorities.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.