Environmental Controls Analyst

About Us

Fagron is the global market leader in pharmaceutical medicine, with products sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of personalized medicine.” Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.

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. This includes, but is not limited to, review of electronic systems, paper-based systems, and logbooks.
• Ensure paper-based processes used for environmental monitoring data are documented and retained appropriately.
• Ensure the accuracy and integrity of environmental monitoring data and records.
• Assist in monitoring 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.
• Support for Audits: Support regulatory and customer audits by providing requested documentation and evidence of compliance.

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.

Benefits

• Competitive salary.
• Comprehensive benefits.
• Performance package.
• Opportunity to be part of an international leader in an expanding industry.

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently.