QC Environmental Monitoring Specialist
Primary Duties : The QC Environmental Monitoring specialist performs sampling activities in support of production. The role performs environmental monitoring of the clean rooms for microbial and particulate counts. The specialist will perform all non-routine sample collection in support of SOP or investigation requirements.
Essential Duties and Responsibilities: Perform environmental monitoring of the clean rooms (under USP and EU specifications) both viable and non-viable monitoring. Read, trend and report environmental, personnel, in-process, raw material, finished product and water testing results. Responsibilities include but are not limited to: Daily preparation of paperwork, supplies, and equipment for EM testing in clean room setting Collect data from the particulate monitoring system and audit system to ensure appropriate sensors are activated. Resolve environmental equipment malfunctions or errors. Perform sampling (e.g., semi-annual static particulate monitoring, quarterly compressed air monitoring) Environmental Monitoring sampling experience including: Total particle sampling using MetOne or Climet particle counter. Surface viable sampling. Viable air sampling using SAS air sampler. Clean room gowning experience. TSA plating Experience. GMP documentation experience Perform cGMP documentation, review sampling worksheets for documentation errors. Provide additional support to QC Microbiologists and complete tasks as needed. Education and Experience Requirements: Minimum 1-2 years' relevant experience. Associate's degree in Science or related field Preferred. Previous experience with pharmaceutical cleanroom environments. Key Skills, Abilities, and Competencies : Computer proficiency (Windows environment). Attention to detail with executing established processes. Ability to write reports and correspondence. Ability to read and interpret documents such as safety rules, operating and maintenance. instructions, and procedure manuals and communicate this information to others. Ability to define problems, collect data, establish facts, and draw valid conclusions.
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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