Environmental Controls Investigator

Fagron Sterile Services

Wichita, KS

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JOB DETAILS

SKILLS

Air Quality, Analysis Skills, Cleanroom, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Environmental Monitoring, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Investigative Reports, Leadership, Maintain Compliance, Manufacturing, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Risk, Risk Analysis, Root Cause Analysis, Safety Compliance, Staff Training, Standard Operating Procedures (SOP), Status Reports, Trend Analysis

LOCATION

Wichita, KS

POSTED

30+ days ago

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.

About the Company

Fagron Sterile Services

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