QC Environmental Monitoring Technician II (6am-2:30pm

Nature and Scope
The EMT II position in the environmental monitoring team is primarily 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 and assists the manufacturing department and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT-II will be able to perform and oversee all activities associated with the environmental monitoring process, including sample collection of water, air, surfaces, compressed gas, and personnel.

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, as well as health and safety requirements.

• Manage assigned daily workload to meet requirements and perform EM and PM 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.

• Conduct 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.

• Performs investigations into environmental excursions and deviations under the guidance of the Environmental Monitoring Supervisor if needed.

• Ensures equipment and supply inventories are maintained and available for use in accordance with department needs.

• The EMT-II is a qualified department trainer and is expected to train and qualify EM personnel on departmental functional requirements including gowning and sampling techniques.

• Ensures only approved sampling materials are utilized at all times.

• Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.

• Ensures that only approved documentation and procedures are utilized at all times.

• 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.

• Minimum 2 years’ experience in environmental monitoring or equivalent experience required, preferably in the pharmaceutical /food/medical device or beverage industry.

• Experience with EMT I Duties and Responsibilities.

• Experience of aseptic technique.

• 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.

• Able to train other junior EMTs.

• 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 holi