Environmental Monitoring Analyst I
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The EM Analyst performs microbiological activities in support of production. The EM Analyst performs environmental monitoring of the cleanrooms for microbial and particulate counts. Directs and coordinates personnel sampling and certification in a cleanroom setting. Performs all non-routine sample collection in support of SOP or investigation requirements.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
Essential Duties and Responsibilities:
- Perform environmental monitoring (EM) of the cleanrooms (under USP and EU specifications) both viable and non-viable monitoring.
- Daily preparation of paperwork, supplies, and equipment for EM testing in a cleanroom setting.
- Perform microbial plating of personnel during manufacturing and personnel qualification.
- Collect data from the particulate monitoring system and audit system to ensure appropriate sensors are activated.
- Resolve environmental equipment malfunctions or errors.
- Perform non-routine or infrequent sampling (e.g., semi-annual static particulate monitoring, quarterly compressed air monitoring).
- Perform cGMP documentation, and review sampling worksheets for documentation errors.
- Maintain current training status on equipment, procedures, and test methods.
This job has no supervisory responsibilities.
Education and/or Experience:
High School Diploma for analyst, and less than two (2) years of related experience. Computer proficiency (Windows environment). Previous experience with pharmaceutical cleanroom environments is a plus.
Ability to write reports and correspondence. Ability to speak effectively before groups of customers or employees. Proficient and comfortable in business meetings and work-related social and business development situations. 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. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
To perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software, and Word Processing software.
Other Skills and Abilities:
- Facilitate the revision and release of all controlled documents.
- Facilitate mandatory reviews of SOP.
- Provide oversight for projects to update/maintain official document templates.
Must pass a background check
Must pass a drug screen
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk radiation and vibration. The noise level in the work environment is usually moderate.
All interested applicants must apply online. Curia 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, or protected veteran status and will not be discriminated against based on disability.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.ID:uDnQdo