Environmental Monitoring Associate, Quality Control

Overview

• This position involves performing environmental monitoring tasks within aseptic environments and controlled areas, ensuring compliance with GMP standards.
• The role requires documenting tasks using GDP principles and LIMS systems, ensuring accurate and compliant record-keeping.
• Candidates will engage in microbial enumeration and incubation processes, supporting laboratory operations and GMP processes.
• Collaborate with cross-functional teams including operations, manufacturing, and facilities to ensure seamless support of GMP operations.
• Participate actively in laboratory meetings, contributing to task management and handover communications effectively.
• Perform general laboratory tasks such as cleaning and equipment preparation, maintaining aseptic qualifications.
• Support laboratory investigations with limited scope, adhering to compliance and safety standards.
• Maintain training for all required tasks, ensuring readiness for laboratory operations and monitoring activities.

Key Responsibilities & Duties

• Conduct environmental monitoring tasks for aseptic environments and controlled areas following SOPs and GMP guidelines.
• Incubate and enumerate microbial growth on environmental monitoring plates, ensuring accurate data collection.
• Document tasks using LIMS systems or laboratory paper documentation, adhering to GDP principles.
• Collaborate with operations, manufacturing, and facilities teams to support GMP processes effectively.
• Participate in laboratory meetings, completing task management tools and handover communications.
• Perform general laboratory tasks including cleaning and equipment preparation, maintaining aseptic qualifications.
• Assist in laboratory investigations with limited scope, ensuring compliance with safety standards.
• Maintain training for all required tasks, ensuring readiness for laboratory operations and monitoring activities.

Job Requirements

• Bachelor’s degree, Associate degree with 2+ years’ experience, or High School Diploma with 4+ years’ experience.
• Strong oral, written, and interpersonal communication skills, with attention to detail.
• Proficiency in basic math and computer skills, including data entry.
• Ability to organize time independently, multitask, and meet objectives in a team-oriented environment.
• Maintain aseptic qualifications, ensuring compliance with environmental monitoring standards.
• Experience with LIMS systems and GDP principles for documentation purposes.
• Knowledge of GMP guidelines and laboratory operations, ensuring compliance and safety.
• Ability to collaborate effectively with cross-functional teams, supporting GMP processes.