Environmental Controls Analyst (1st Shift)
Fagron Sterile Services US (FSS) · Wichita, KS · 3 days ago
ManufacturingFull-time
Key Responsibilities
- Review Environmental Monitoring Data: Complete review of environmental monitoring data to ensure alignment with Good Documentation Practices.
- Ensure Accuracy and Integrity: Ensure the accuracy and integrity of environmental monitoring data and records.
- Maintain Compliance: Assist in monitoring the Environmental Management System (EMS).
- Report Adverse Events: Report adverse events identified during review of environmental monitoring data to department leadership.
- Track and Trend Data: Assist in the tracking and trending of EM data to identify repeat adverse events and any potential trends within the data.
- Initiate Investigations: Complete data evaluation to determine if objective evidence exists for an identified adverse event that can be used to remediate the event.
- Support Process Improvement: Work collaboratively as a team to improve existing environmental monitoring processes and / or assist in the creation of new environmental monitoring procedures and training course plans.
- Provide Support for Investigations: Support investigations.
- Audits: Support regulatory and customer audits by providing requested documentation and evidence of compliance.
Basic Qualifications
- Analytical skills for interpreting environmental data and identifying compliance issues.
- Attention to detail to ensure accuracy in data entry, reports, and compliance documentation.
- Good organizational skills.
- Experience with Microsoft Word, PowerPoint, and Excel required.
- Ability to communicate efficiently and work collaboratively as a team.
- A degree in Biology or Data Analysis OR minimum of 2 years of experience in a pharmaceutical manufacturing company required.