Nature and Scope

The Environmental Monitoring Team is responsible for the activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with the manufacturing department and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT I position is primarily responsible for performing environmental monitoring activities including sample collection of water, air (viable and non-viable), compressed gas, surfaces, and personnel within the classified areas of the manufacturing facility.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
• Manage assigned daily workload to meet requirements and perform sampling as per the schedule.
• Must complete and maintain gowning qualifications for support areas as well as the Aseptic Processing Area to work in clean rooms.
• Perform environmental monitoring activities including sampling of air (Viable and Non-viable), compressed air and nitrogen, surface, and personnel inside the classified manufacturing areas.
• Conduct water sampling throughout facility.
• Complete incubation, transfer and final reading of samples if needed.
• Record results and report deviations as per specifications.
• Capture sampling life cycles in the LIMS software and assist with data entry for retrieval and trending from Labware LIMS.
• Maintain accurate records of work performed in Labware LIMS and Laboratory documentation systems according to Good Documentation Practices, Standard Operating Procedures (SOPs) and policies.
• Maintains compliance with all required SOPs and policies.
• Communicate any discrepancies or deviations to supervision/management upon discovery.
• Author or help data collection for assigned investigation report related to EM/PM events.
• Perform clean room behavior and area assessments as per procedures if needed.
• Review environmental and personnel monitoring sample results in Labware LIMS if needed.
• Input data/results into database and conduct trend analysis.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• High School Diploma or GED equivalent required. Associate degree in microbiology, biology or related scientific field preferred.
• One year experience in academic or industry work experience in laboratory setting or manufacturing with focus on microbiology preferred.
• Knowledge of aseptic technique preferred.
• Must be able to maintain APA gown qualification for EM support.
• Ability to perform basic mathematical calculations.
• Ability to work independently and as a team with minimal supervision.
• Organization and attention to detail.
• Excellent communication skills (Oral and Written).
• Working knowledge of MS-Office software and PC Skills Required.
• Good work ethic and highly motivated.
• Good time-management skills.
• Ability to work in a fast-paced environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime, weekend and holidays as needed.

Physical Environment and Requirements

• Physically able to wear and aseptically don cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE is essential for the health and safety of employees.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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