Job Title: Quality Environmental Monitoring Specialist

Job Description

The Quality Environmental Monitoring Specialist will work on the 1st shift to conduct environmental monitoring and sampling within cleanrooms and controlled areas. The role involves maintaining accurate documentation and adhering to quality procedures to ensure cleanliness and compliance.

Responsibilities

• Perform environmental monitoring of cleanrooms and controlled areas, including viable air, non-viable particles, critical surface monitoring, and personnel monitoring.
• Collect routine environmental samples from surfaces, air, and water.
• Maintain accurate and complete documentation of sampling information and results in compliance with Good Documentation Practices (GDP).
• Label environmental samples appropriately and submit them to the laboratory via LIMS.
• Submit finished good products for additional testing.
• Review and perform trending on environmental monitoring results.
• Assist with investigations related to out-of-specification (OOS) results, excursions, or contamination events.
• Adhere to internal quality procedures, specifically related to proper gowning, hygiene, and microbial control, to maintain cleanliness within cleanrooms.
• Assist in the development and implementation of processes, reports, data analysis, and procedures within the defined area of specialization.
• Perform audits to review all related documentation for completeness, accuracy, and ensure the product and reports meet all specifications.

Essential Skills

• Laboratory experience with emphasis on biology and microbiology.
• Proficiency in aseptic techniques and GMP practices.
• Strong documentation skills and experience with environmental monitoring and sampling.
• Familiarity with LIMS, SOPs, and labeling practices.
• Experience in quality control and cleanroom environments.
• Ability to conduct investigations, handle deviations, and implement CAPA procedures.

Additional Skills & Qualifications

• High school graduate or GED required.
• Associate or bachelor’s degree in biology, microbiology, or a science-related field preferred.
• 0 to 2 years of work experience within a manufacturing environment, with GMP experience preferred.
• Attention to detail in sampling techniques and previous experience with environmental monitoring and aseptic technique preferred.
• Strong time management, communication, and critical thinking skills.
• Familiarity with LIMS or submission of samples to a laboratory.
• Experience working with aseptic technique within an FDA-regulated environment.
• Past participation in regulatory audits (FDA, ISO, etc.).

Work Environment

The role operates during the 1st shift from 8:00 am to 4:30 pm. The Quality Assurance team consists of seven members, including six QA Engineers. The specialist will also interact with a team of 9-10 people in Quality Control, who conduct in-process testing and visual inspection. The Readycare division focuses on wipes for cosmetic and pharmaceutical industries, serving long-term care facilities, hospitals, and retail spaces.