Environmental Controls Analyst (1st Shift)
Fagron · Wichita, KS · 1 mo ago
Quality AssuranceFull-time
About the role
An Environmental Control Analyst is responsible for ensuring that Environmental Monitoring adheres to regulations, standards, and internal policies. The role typically involves reviewing and analyzing environmental data, ensuring compliance with SOP standards, and potential process improvement initiatives.
Responsibilities
- Review Environmental Monitoring Data: Complete review of environmental monitoring data to ensure alignment with Good Documentation Practices. Will include, but not limited to, review of electronic systems, paper-based systems, and logbooks. Ensure the accuracy and integrity of environmental monitoring data and records.
- Ensure the accuracy and integrity of environmental monitoring data and records.
- Assist in the monitoring of the Environmental Management System (EMS).
- Reporting, Tracking, and Trending of Adverse Events: Report adverse events identified during review of environmental monitoring data to department leadership. Assist in the tracking and trending of EM data to identify repeat adverse events and any potential trends within the data. Complete initiation of investigations when adverse events are identified and assist in writing investigations as needed.
- Issue Resolution: Complete data evaluation to determine if objective evidence exists for an identified adverse event that can be used to remediate the event. 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.
- Audit Support: Support regulatory and customer audits by providing requested documentation and evidence of compliance.
Requirements
- 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.
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.
Skills
- 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.
Benefits
Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.
Pay
Competitive salaries.
Schedule
N/A
Benefits
A wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.