Deviation Investigator

United Pharma; North Carolina; On-site; USD 70,000 - 110,000; Full time

Job summary

United Pharma is seeking an experienced Deviation Investigator to support quality and compliance in a regulated Pharma/Biotech manufacturing environment. The role involves investigating deviations, identifying root causes, developing CAPAs, and maintaining compliant documentation.

This position requires strong analytical, problem-solving, and technical writing skills, plus knowledge of GDP/GMP and regulatory requirements.

Qualifications

• Analytical, problem-solving, and technical writing skills are essential.
• Experience with documenting investigations and CAPA.
• Strong attention to detail and ability to review complex information.
• Familiarity with GDP, GMP, GLP and regulatory requirements.
• Excellent written and verbal communication skills.
• Ability to develop corrective actions based on root-cause analysis.
• Experience in a regulated cGMP environment (Pharma/Biotech/Medical devices).

Responsibilities

• Identify, document, assess, and investigate deviations from SOPs and regulatory requirements.
• Lead or support root cause investigations using problem-solving methodologies.
• Develop and implement CAPA plans based on investigation findings.
• Review records to determine potential causes and impact on product and process.
• Prepare clear deviation and investigation reports complying with GDP.
• Ensure documentation meets GDP and company quality requirements.
• Track investigation and CAPA activities through completion and documentation.

Skills

Analytical thinking

Problem-solving

Technical writing

Attention to detail

Written & verbal communication

Education

Bachelor's or Associate degree in Life Sciences / Engineering / Medical Sciences / Quality Management

Job description

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.

Key Responsibilities:

• 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.

Skills & 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.