at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
The EC Investigator is responsible for investigating environmental monitoring deviations within cleanroom environments to ensure compliance with regulatory standards and SOP policies and procedures. This role involves conducting thorough root cause analysis, assessing the impact of events to product and cleanroom, and collaborating with cross-functional teams to implement corrective and preventive actions. The EC Investigator plays a key role in maintaining product quality, regulatory compliance, and ensuring a safe and controlled cleanroom environment.
Key Responsibilities
Investigation of Deviations:
- Respond to and investigate environmental deviations within cleanroom environments, including abnormalities in air quality (e.g., particulate levels, airflow), temperature, humidity, pressure, SOP violations, and microbial contamination that exceed limits.
- Document deviations thoroughly, providing clear descriptions of the issue, potential causes, and any immediate corrective actions taken.
- Conduct root cause analysis (RCA) of deviations, utilizing tools such as the 5 Whys, Fishbone diagrams, or Failure Mode Effects Analysis (FMEA) to identify underlying issues.
Impact Assessment and Risk Evaluation:
- Assist in assessing the impact of deviations on product quality, safety, and regulatory compliance by providing information to determine whether the deviation poses a risk to the safety of the product, personnel, or the environment.
- Communicate findings to quality assurance, production, engineering, and affected personnel when appropriate, to ensure proper understanding of the deviation's implications and adhere to any remediation actions associated with the event investigating.
Documentation and Reporting:
- Maintain accurate records of all deviations, including investigation reports, trending data, and any correspondence with interdepartmental personnel and leadership.
- Prepare detailed deviation reports that are compliant with Good Manufacturing Practices (GMP), ISO standards, and other applicable regulatory guidelines.
- Provide regular status updates and reports on open investigations to management.
Collaboration with Cross-Functional Teams:
- Collaborate with the quality assurance (QA), engineering, and manufacturing teams to ensure that cleanroom conditions are maintained according to established standards and specifications.
- Assist in training cleanroom personnel on the importance of environmental monitoring, the identification of deviations, and reporting protocols.
Regulatory Compliance:
- Ensure all cleanroom deviations are handled in accordance with relevant regulatory guidelines, such as FDA, EMA, ISO 14644 (Cleanroom Standards), and other industry-specific requirements.
- Support audits and inspections by providing necessary deviation records, investigation reports, and CAPA evidence.
