QC Scientist I - Environmental Monitoring Night shift

Thermo Fisher Scientific•Greenville, NC

7d•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. This hands-on role performs environmental monitoring within classified cleanrooms, aseptic processing areas, and filling suites; it is not a traditional bench laboratory position. The employee works alongside manufacturing teams to help maintain controlled environments in accordance with approved procedures and regulatory requirements. The position provides experience in aseptic processing, Environmental Monitoring, GMP, and sterile manufacturing operations. It is described as an entry-level opportunity that may provide 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.

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 effective shift handoffs and communication with manufacturing, Quality, supervisors, and colleagues.
Ability to work independently and collaboratively.
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, contemporaneous records.
Willingness and ability to work a 12-hour rotating night-shift schedule.
Ability to 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 is preferred.
Previous experience in Environmental Monitoring, microbiology, pharmaceutical manufacturing, aseptic processing, cleanroom operations, or another regulated environment is preferred but not required for candidates with an appropriate scientific foundation and ability to learn.
Previous microbiological testing or Environmental Monitoring experience is particularly valuable.
Candidates with an associate degree and relevant pharmaceutical or Environmental Monitoring experience may also be considered.
Interest in or understanding of Environmental Monitoring within a pharmaceutical manufacturing environment.

Responsibilities

Perform routine Environmental Monitoring activities in classified cleanrooms and aseptic processing areas supporting sterile filling operations.
Collect environmental samples in manufacturing and filling suites according to approved procedures.
Perform monitoring in aseptic core areas, isolator lines, and other controlled manufacturing environments.
Follow procedures for environmental and personnel monitoring while maintaining appropriate aseptic technique.
Document activities and results accurately in accordance with Good Documentation Practices, ALCOA principles, GMP requirements, and site procedures.
Generate 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 effective 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 as appropriate.
Perform other duties as assigned.