Associate Specialist, Environmental Monitoring

Merck KGaA Darmstadt Germany - Wilson, NC

Full-time

Onsite - Wilson, NC

Chemical Manufacturing

About the position

The Associate Specialist in Environmental Monitoring plays a crucial role in supporting performance qualification activities within the pharmaceutical industry. This position involves the collection and analysis of environmental samples, ensuring compliance with quality standards, and contributing to continuous improvement initiatives. The specialist will also be responsible for data management and reporting, as well as maintaining a safe and organized work environment.

Responsibilities

• Directly support performance qualification activities
• Collection of utility systems samples including water, clean steam, and clean dry air
• Execute environmental sampling of classified areas including active viable air, non-viable air, and surface sampling
• Compile and author annual reviews
• Provide data entry, review, and approval as required in GLIMS
• Provide summaries of test results to appropriate personnel as necessary
• Compile and evaluate environmental monitoring data for adverse trends
• Conduct investigations for deviations and Out of Specification results
• Interprets our Company's Quality policies, GMP's and other agency regulations for application to Wilson Operations
• Identifies and implements continuous improvement activities
• Maintains 5S organization and identifies improvement opportunities
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
• All other responsibilities as assigned by leadership

Requirements

• Associate degree in sciences or related field
• Minimum two (2) years of GMP pharmaceutical industry experience
• Aseptic filling, environmental monitoring and process simulations
• Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
• Ability to interpret our Company's Quality Policies, Procedures and Guidelines for daily application
• Ability to independently reply to basic requests for data and trending of data
• Willing to work irregular hours to support multi-shift operation on an as needed basis

Nice-to-haves

• Technical writing experience
• GLIMS
• Ability to learn new processes and computerized systems with limited support
• Continuous improvement, LEAN manufacturing, problem solving, and/or Right First Time methodologies
• Effective and strategic written and verbal communication skills including technical writing experience with investigations, change requests, standard operating procedures, protocols, etc.