Deviation Investigator
Job in
Chapel Hill, Orange County, North Carolina, 27517, USA
Listed on 2026-09-30
Listing for:
United Pharma
Full Time
position Listed on 2026-09-30
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
We are seeking an experienced Deviation Investigator to support quality and compliance activities within a regulated Pharma/Biotech manufacturing environment
. The role will be responsible for investigating deviations, identifying root causes, developing CAPAs, maintaining compliant documentation, and supporting continuous improvement and regulatory readiness.
- Identify, document, assess, and investigate deviations from SOPs, quality standards, procedures, and regulatory requirements.
- Lead or support root cause investigations using appropriate problem-solving and investigation methodologies.
- Develop and implement effective CAPA plans based on investigation findings.
- Review manufacturing, laboratory, equipment, and process records to determine potential causes and impact.
- Prepare clear, accurate, and timely deviation and investigation reports
. - Ensure investigation documentation meets Good Documentation Practices (GDP) and company quality requirements.
- Evaluate potential product, process, equipment, and compliance impacts associated with deviations.
- Track investigation and CAPA activities through completion and ensure required actions are properly documented.
- Analyze deviation data and identify recurring trends and opportunities for continuous improvement
.
Qualifications:
- Associate or Bachelor’s degree in Life Sciences, Engineering, Medical Sciences, Quality Management, or a related field preferred.
- 2+ years of relevant experience in a regulated cGMP environment
, including Pharma, Biologics, Medical Device, Manufacturing, or Engineering. - Strong experience with deviation investigations, root cause analysis, CAPA, and quality documentation
. - Working knowledge of GMP/GLP, regulatory requirements, and Good Documentation Practices (GDP).
- Strong analytical, problem-solving, technical writing, and attention-to-detail skills.
- Ability to review complex information, identify potential root causes, and develop appropriate corrective actions.
- Strong written and verbal communication skills.
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