Job Title: QA Deviation Investigator

Job Description

As a QA Deviation Investigator, you will play a crucial role in analyzing and investigating deviations or non-conformances within a regulated environment. Utilizing problem-solving tools like root cause analysis, you will collect and analyze relevant data to identify patterns and potential causes. Your findings will be documented comprehensively, and you will collaborate with various departments to implement corrective and preventive actions (CAPAs). You will also participate in client communications and provide timely written documentation of investigations.

Responsibilities

• Analyze and investigate deviations or non-conformances using problem-solving tools such as root cause analysis.
• Collect and analyze relevant data to identify patterns, trends, or potential causes.
• Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.
• Collaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).
• Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.
• Participate in client communications and responses, working closely with program team leads, quality, and management.

Essential Skills

• Experience in CAPA, quality assurance, and root cause analysis.
• Knowledge of deviations in pharmaceutical settings and GMP/FDA regulations.
• Strong technical writing and communication skills.
• Proficiency in quality processes and Six Sigma methodologies.

Additional Skills & Qualifications

• BS/BA in biology, biochemistry, chemistry, or other science-related fields.
• 1+ years of experience with problem-solving tools like 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, preferably in biologics/pharmaceuticals.
• Ability to evaluate data and make recommendations based on trends and trend analysis.
• Ability to work effectively in a fast-paced environment and prioritize tasks.
• Ability to facilitate meetings for desired outcomes.

Work Environment

The role requires working Monday through Friday, with core hours of 9am to 3pm, and flexibility in start and end times. You will collaborate with any department needed for deviations, not necessarily limited to upstream or downstream processes.