QA Deviation Investigator

Job Title: QA Deviation Investigator

Job Description

As a QA Deviation Investigator, you will analyze and investigate deviations or non-conformances using problem-solving tools such as root cause analysis. You will collect and analyze relevant data to identify patterns, trends, or potential causes, documenting your findings comprehensively and objectively. Collaborating with various departments, you will gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs). You will also provide timely written documentation of investigations and communicate recommendations based on investigation outcomes. Additionally, you will participate in client communications and responses, working closely with program team leads, quality, and management.

Responsibilities

• Analyze deviations or non-conformances using problem-solving tools like root cause analysis.
• Collect and analyze data related to deviations to identify patterns, trends, or potential causes.
• Document findings in a comprehensive and objective manner.
• Collaborate with departments to gather information and implement corrective actions.
• Provide timely written documentation of investigations.
• Communicate recommendations based on investigation outcomes.
• Participate in client communications and responses.

Essential Skills

• Experience with CAPA, quality assurance, root cause analysis, and deviations.
• Knowledge of pharmaceutical, GMP, and FDA regulations.
• Technical writing and quality processes expertise.
• Experience in a regulated environment, preferably in biologics/pharmaceuticals.

Additional Skills & Qualifications

• Bachelor's degree in biology, biochemistry, chemistry, or a science-related field.
• 1+ years of experience with problem-solving tools (Root Cause Analysis and/or LEAN/six sigma).
• 1+ years of experience in technical writing and/or deviation writing.
• 3+ years of experience in a regulated environment.
• Solid technical writing and communication skills.
• Ability to evaluate data and make recommendations based on trends.
• Ability to work effectively in a fast-paced environment and prioritize tasks.
• Ability to facilitate meetings for desired outcomes.