Quality Assurance Deviation Specialist
Harba Solutions Inc., Indianapolis, IN, United States
Lead and document investigations of deviations, nonconformances, and other quality events across multiple technical and manufacturing areas
Partner with subject matter experts to perform fact-based investigations and determine root cause
Apply structured root cause analysis tools (e.g., Fishbone diagrams, 5 Whys, etc.) to support investigations
Gather, analyze, and interpret technical and quality data to support defensible conclusions
Develop clear, concise, and accurate investigation reports suitable for GMP and regulatory review
Translate complex technical processes into simplified, well-structured documentation
Collaborate with cross-functional internal and external stakeholders to ensure complete and accurate investigation outcomes
Identify trends across historical quality events to support continuous improvement and recurrence prevention
Support development and implementation of corrective and preventive actions (CAPAs), including process and system improvements
Qualifications
Bachelor’s degree in a scientific, engineering, or technical discipline
3+ years of experience in technical writing within a GMP-regulated environment (pharma, biotech, or other regulated industry preferred)
Strong understanding of GMP manufacturing processes and regulatory expectations
Experience conducting deviation, nonconformance, or quality investigations
Proficiency with root cause analysis methodologies (Fishbone, 5 Whys, etc.)
Strong written communication skills with the ability to produce clear, accurate technical documentation
High attention to detail and strong organizational skills
Ability to collaborate effectively across technical, quality, and operational teams
Proficiency in Microsoft Word, Excel, and electronic document management systems (EDMS)
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Partner with subject matter experts to perform fact-based investigations and determine root cause
Apply structured root cause analysis tools (e.g., Fishbone diagrams, 5 Whys, etc.) to support investigations
Gather, analyze, and interpret technical and quality data to support defensible conclusions
Develop clear, concise, and accurate investigation reports suitable for GMP and regulatory review
Translate complex technical processes into simplified, well-structured documentation
Collaborate with cross-functional internal and external stakeholders to ensure complete and accurate investigation outcomes
Identify trends across historical quality events to support continuous improvement and recurrence prevention
Support development and implementation of corrective and preventive actions (CAPAs), including process and system improvements
Qualifications
Bachelor’s degree in a scientific, engineering, or technical discipline
3+ years of experience in technical writing within a GMP-regulated environment (pharma, biotech, or other regulated industry preferred)
Strong understanding of GMP manufacturing processes and regulatory expectations
Experience conducting deviation, nonconformance, or quality investigations
Proficiency with root cause analysis methodologies (Fishbone, 5 Whys, etc.)
Strong written communication skills with the ability to produce clear, accurate technical documentation
High attention to detail and strong organizational skills
Ability to collaborate effectively across technical, quality, and operational teams
Proficiency in Microsoft Word, Excel, and electronic document management systems (EDMS)
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