QA Deviation Investigator

Job Description

We are seeking a QA Deviation Investigator to analyze and investigate deviations or non-conformances, using problem-solving tools like root cause analysis. This role involves collecting relevant data, analyzing it to identify patterns or potential causes, and documenting findings comprehensively. You will collaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs). Timely written documentation of investigations and communication of recommendations based on outcomes are essential.

Responsibilities

• Analyze and investigate deviations or non-conformances using root cause analysis.
• Collect relevant data and information related to deviations.
• Analyze data to identify patterns, trends, or potential causes.
• Document findings in a comprehensive and objective manner.
• Collaborate with various departments to gather information and evaluate causal factors.
• Implement corrective and preventive actions (CAPAs).
• Provide timely written documentation of investigations.
• Communicate recommendations based on investigation outcomes.
• Participate in client communications and responses.
• Work closely with program team leads, quality, and management.

Essential Skills

• Experience with CAPA, quality assurance, root cause analysis, and deviations.
• Knowledge of pharmaceutical industry regulations, including GMP and FDA.
• Proficiency in technical writing and quality processes.
• Experience with problem-solving tools such as Root Cause Analysis and/or LEAN/Six Sigma.
• Strong technical writing and communication skills.
• Ability to evaluate data and make recommendations based on trend analysis.
• Ability to work effectively in a fast-paced environment and prioritize tasks.
• Ability to facilitate meetings for desired outcomes.