Environmental Monitoring Associate

Position Title

Environmental Monitoring Associate

Location:

Summit West, S-12

Duration: 06 Months

Shift: Sunday - Thursday 4am-12 pm

This position will work both independently and with the team to perform routine and non-routine Environmental Monitoring in GMP areas of Summit West CAR T Manufacturing and Warehouses. The EM associate works both independently and with the team to collect environmental monitoring samples for the controlled, non-classified areas as well as controlled non-aseptic and aseptic processing areas of manufacturing.

Knowledge, Skills, and Abilities:

• Good knowledge of Microsoft Word and Excel.
• Familiar with requirements for cGMP manufacturing.
• Ability to stand for extended periods of time; ability to become gown qualified and perform EM duties within the media and cell processing suites.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
• Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
• Routine exposure to human blood components. Exposure to strong magnets is likely.
• Reliable with ability to respond to challenges in a positive, and objective manner.
• Adaptable to dynamic conditions, work practices, and schedules.
• Able to communicate effectively with S12 functional areas and external agencies.

• Requires a High School diploma or equivalent. Associate or Bachelor's degree in a scientific discipline preferred.
• 1-2 years demonstrated work experience in a regulated industry.

• Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
• Follow directions properly, work cooperatively as an individual contributor and as a team member.
• Communicate effectively with Manufacturing Operations peers, cross-functional peers and management.
• Assist in troubleshooting and solving problems that may come up in the day to day operation of the department.
• Perform EM monitoring in aseptic process qualifications, such as aseptic gowning and media fill reads.
• Perform Environmental Monitoring on a routine and non-routine basis for all S12 GMP manufacturing and associated warehouse areas.
• Under the guidance of management, support special project work and continuous improvement initiatives for MO.
• Assist with investigations & CAPAs associated with EM excursions.
• Perform all other duties as assigned.

• This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken.
• The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment.
• The incumbent may be required to stand and walk for extended amount of time.
• The incumbent may be required to work hazardous materials.
• Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
• Flexible to work shift structures.
• Change to work timings and assigned tasks may occur at a very short notice to support business needs.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by the management.