Senior QA Deviation & Investigation Writer

United Pharma; Michigan; On-site; USD 110,000 - 170,000; Full time

Job summary

United Pharma in the United States seeks a seasoned QA Deviation Writer/Investigation Writer to support the Quality Assurance organization within a regulated pharmaceutical manufacturing environment. The consultant will help reduce a deviation backlog while improving the quality, consistency, completeness, and regulatory defensibility of investigation documentation.

The ideal candidate has 10+ years of deviation and investigation writing experience in aseptic fill‑finish manufacturing, conducts

Qualifications

• 10+ years of professional experience in regulated manufacturing.

Responsibilities

• Provide hands-on QA deviation and investigation writing support to reduce backlog.
• Lead and/or support investigations related to manufacturing deviations in aseptic fill-finish operations.
• Review deviation records, manufacturing documentation, batch records, SOPs, equipment records, environmental monitoring data, and other relevant evidence.
• Develop clear, concise, technically sound, and GMP-compliant investigation reports.
• Identify and clearly distinguish between root cause, contributing causes, and potential causes.
• Evaluate the effectiveness and adequacy of existing controls when determining root cause.
• Develop investigation conclusions that are supported by documented evidence and objective data.
• Ensure conclusions are logically connected to the investigation evidence and established root cause.
• Develop and/or support CAPA plans that directly address the identified root cause and contributing factors.
• Ensure CAPAs are specific, measurable, sustainable, and appropriately scoped to prevent recurrence.
• Evaluate whether proposed CAPAs adequately address the risks identified during the investigation.
• Investigate complex, recurring, or potentially high-impact deviations and determine appropriate investigation depth.
• Collaborate closely with QA, Manufacturing, Engineering, Validation, QC, Operations, and other cross-functional stakeholders.
• Conduct interviews with subject matter experts and personnel involved in the event to establish an accurate timeline and sequence of events.
• Perform detailed review of historical deviations, trends, batch history, equipment history, and related quality records where applicable.
• Identify recurring trends and potential systemic issues contributing to deviations.
• Assess product, process, equipment, and patient impact as required by the investigation.
• Support appropriate risk assessments and impact assessments associated with deviations.
• Ensure investigation documentation meets internal quality standards and applicable cGMP requirements.
• Ensure investigations are written in a manner that can withstand scrutiny from FDA and other regulatory authorities.
• Provide clear scientific and technical justification for investigation conclusions.
• Support QA management in reviewing and improving the overall quality of deviation documentation.
• Identify gaps in existing investigation narratives and recommend improvements.
• Ensure deviation records are completed accurately, consistently, and within established timelines.
• Participate in investigation review meetings and provide technical justification for proposed conclusions and CAPAs.
• Support closure of deviations by ensuring all investigation actions and documentation requirements are appropriately addressed.

Skills

Deviation writing

Investigation writing

Root cause analysis

CAPA development

Technical writing

Cross-functional collaboration

Regulatory inspections defense

GMP knowledge

Timeline management

Job description

United Pharma in the United States seeks a seasoned QA Deviation Writer/Investigation Writer to support the Quality Assurance organization within a regulated pharmaceutical manufacturing environment. The consultant will help reduce a deviation backlog while improving the quality, consistency, completeness, and regulatory defensibility of investigation documentation.

The ideal candidate has 10+ years of deviation and investigation writing experience in aseptic fill‑finish manufacturing, conducts