The posting
Work Schedule
12 hr shift/nights
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift
Job Description
Location: Greenville, NC
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
- Medical, Dental, & Vision benefits – effective Day 1
- Paid Time Off & Holidays
- 401K Company Match up to 6%
- Tuition Reimbursement – eligible after 90 days!
- Employee Referral Bonus
- Employee Discount Program
- Recognition Program
- Charitable Gift Matching
- Company Paid Parental Leave
- Career Advancement Opportunities
Location/Division Specific Information
Greenville, NC
Hours: 6:00pm – 6:00am, 2-2-3 rotating schedule with 15% shift differential
As part of the Drug Product Division (DPD), our Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development through commercialization.
This position supports our sterile manufacturing operations through Environmental Monitoring activities performed within classified and aseptic processing areas. The Environmental Monitoring team works alongside manufacturing throughout the filling process to help ensure controlled environments are maintained in accordance with established procedures and regulatory requirements.
How will you make an impact?
As a QC Scientist I – Environmental Monitoring, you will perform Environmental Monitoring activities in support of sterile pharmaceutical filling operations. This is a hands-on role that works directly within classified manufacturing environments and is not a traditional bench laboratory position.
You will collect environmental samples within filling suites, monitor controlled environments, follow aseptic practices and good documentation requirements, and accurately record and communicate results. You will work closely with Operations, Quality, and other team members to help maintain the environmental controls necessary to manufacture sterile pharmaceutical products safely and compliantly.
This is an excellent opportunity to begin or grow a career within the pharmaceutical industry while gaining experience in aseptic processing, Environmental Monitoring, Good Manufacturing Practices (GMP), and sterile manufacturing operations. The hiring manager described the position as an entry point into pharmaceutical operations that can provide exposure to future opportunities across Quality, Manufacturing, data auditing, and the Environmental Monitoring organization.
What will you do?
- 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 in accordance with approved procedures.
- Perform monitoring activities associated with aseptic core areas, isolator lines, and other controlled manufacturing environments.
- Follow established procedures for environmental and personnel monitoring while maintaining appropriate aseptic technique.
- Accurately document activities and results 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 the appropriate team members.
- Communicate effectively with assigned manufacturing lines, supervisors, and incoming shifts to ensure appropriate handoffs and continuity of work.
- Complete routine Environmental Monitoring activities performed on weekly, biweekly, monthly, and production-driven schedules.
- Maintain assigned equipment and verify equipment is ready and appropriate for use.
- Follow Standard Operating Procedures (SOPs), safety requirements, and established Quality procedures.
- Maintain required training and qualification status for work within classified and aseptic areas.
- Work both 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.
The role requires considerable time on your feet and regular movement throughout manufacturing areas. Depending on the activity and equipment involved, employees may also be required to lift approximately 10–40 pounds.
Education
- Bachelor’s degree in Biology, Microbiology, or another related science field is preferred.
- 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.
Experience
This is an entry-level pharmaceutical opportunity.
Previous experience in Environmental Monitoring, microbiology, pharmaceutical manufacturing, aseptic processing, cleanroom operations, or another regulated environment is preferred but not required for candidates who demonstrate the appropriate scientific foundation and ability to learn.
Candidates with an associate degree and relevant pharmaceutical or Environmental Monitoring experience may also be considered. Previous experience with microbiological testing or Environmental Monitoring is particularly valuable.
Knowledge, Skills and Abilities
- 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.
- Interest in or understanding of Environmental Monitoring within a pharmaceutical manufacturing environment.
- Ability to learn and apply aseptic techniques and gowning requirements.
- Strong written and verbal communication skills.
- Ability to communicate effectively during shift handoffs and with manufacturing, Quality, supervisors, and other colleagues.
- Ability to work effectively both 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.
Physical Requirements / Work Environment
This position requires work within classified cleanroom and aseptic manufacturing environments and the ability to successfully complete applicable gowning and aseptic qualifications.
The position requires extended periods of standing and walking as well as the ability to bend, reach, stoop, kneel, squat, and crouch periodically. Employees must be able to lift, carry, and move equipment and materials associated with Environmental Monitoring activities, typically weighing approximately 10–40 pounds.
The role also requires sufficient hand and finger dexterity to operate equipment and computer systems, as well as visual acuity necessary to read procedures, documentation, computer displays, and equipment.
