QC Scientist I - Environmental Monitoring - Night shift

Thermo Fisher Scientific•Greenville, NC

9d•Onsite

About The Position

The QC Scientist I – Environmental Monitoring supports sterile pharmaceutical filling operations at Thermo Fisher Scientific’s Drug Product Division site in Greenville, North Carolina. The role performs hands-on environmental monitoring within classified cleanrooms, aseptic processing areas, and filling suites to help maintain controlled environments in accordance with approved procedures and regulatory requirements. It is not a traditional bench laboratory position. The position works closely with Manufacturing, Quality, and other colleagues to collect samples, monitor controlled environments, follow aseptic practices, and accurately document and communicate results. It offers entry-level exposure to aseptic processing, GMP, environmental monitoring, and sterile manufacturing operations, with potential exposure to future opportunities across Quality, Manufacturing, data auditing, and the Environmental Monitoring organization. The schedule is 6:00 p.m. to 6:00 a.m. on a 2-2-3 rotating schedule, with a 15% shift differential. Work takes place in classified cleanroom and aseptic manufacturing environments and involves extended standing and walking, movement through manufacturing areas, and lifting and handling equipment and materials typically weighing approximately 10–40 pounds. Applicable gowning and aseptic qualifications are required.

Requirements

An associate degree in a science-related field is required; equivalent combinations of education, training, and relevant work experience may be considered where appropriate, provided the minimum education requirement is met.
Strong attention to detail and commitment to accurate documentation.
Ability to learn and consistently follow GMP, Good Documentation Practices, ALCOA principles, SOPs, and other regulatory requirements.
Ability to learn and apply aseptic techniques and gowning requirements.
Strong written and verbal communication skills, including communicating during shift handoffs and with Manufacturing, Quality, supervisors, and colleagues.
Ability to work effectively independently and as part of a collaborative team.
Proactive approach to completing assigned work and communicating roadblocks or concerns.
Ability to organize work and manage assigned activities in a fast-paced manufacturing environment.
Working knowledge of Microsoft Office applications and ability to accurately enter and transcribe data.
Ability to follow detailed procedures and maintain accurate, legible, and contemporaneous records.
Willingness and ability to work a 12-hour rotating night-shift schedule.
Ability to successfully complete applicable gowning and aseptic qualifications.
Ability to stand and walk for extended periods and periodically bend, reach, stoop, kneel, squat, and crouch.
Ability to lift, carry, and move equipment and materials typically weighing approximately 10–40 pounds.
Sufficient hand and finger dexterity to operate equipment and computer systems, and visual acuity to read procedures, documentation, computer displays, and equipment.

Nice To Haves

Bachelor’s degree in Biology, Microbiology, or another related science field.
Previous experience in Environmental Monitoring, microbiology, pharmaceutical manufacturing, aseptic processing, cleanroom operations, or another regulated environment; not required for candidates who demonstrate the appropriate scientific foundation and ability to learn.
Relevant pharmaceutical or Environmental Monitoring experience for candidates with an associate degree.
Previous microbiological testing or Environmental Monitoring experience.

Responsibilities

Perform routine Environmental Monitoring activities within classified cleanrooms and aseptic processing areas in support of sterile filling operations.
Collect environmental samples within manufacturing and filling suites according to approved procedures.
Perform monitoring in aseptic core areas, isolator lines, and other controlled manufacturing environments.
Follow environmental and personnel monitoring procedures while maintaining appropriate aseptic technique.
Document activities and results accurately in accordance with Good Documentation Practices, ALCOA principles, GMP requirements, and site procedures.
Generate and record accurate, complete, legible, and contemporaneous documentation.
Review Environmental Monitoring information and communicate observations, issues, or unexpected results to appropriate team members.
Communicate with assigned manufacturing lines, supervisors, and incoming shifts to support handoffs and continuity of work.
Complete routine monitoring activities on weekly, biweekly, monthly, and production-driven schedules.
Maintain assigned equipment and verify it is ready and appropriate for use.
Follow SOPs, safety requirements, and established Quality procedures.
Maintain required training and qualification status for work in classified and aseptic areas.
Work independently and collaboratively after completing the appropriate training and qualification process.
Maintain an organized work area and appropriately handle Environmental Monitoring equipment and materials.
Escalate roadblocks, incomplete activities, environmental concerns, or documentation issues to supervision.
Perform other duties as assigned.