Environmental Controls Investigator

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13550138

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.