QC Scientist 1 (Nights)

Regulatory Jobs; Greenville (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Thermo Fisher Scientific is seeking a QC Scientist I to perform environmental monitoring in sterile production areas. The role involves aseptic gowning, cleanroom work, and ensuring product safety and quality.

Typical shift is 6pm-6am on a rotating schedule, with potential night, weekend, and holiday work. The ideal candidate holds a Bachelor's degree in a related field and demonstrates strong attention to detail, GMP knowledge, and proficiency with analytical techniques such as HPLC and GC.

Qualifications

• Bachelor's degree required in a related scientific field.
• Proficiency with GMP regulations, documentation practices, and pharmaceutical quality standards.
• Strong attention to detail and data integrity.

Responsibilities

• Execute validated environmental test methods for routine environmental monitoring in clean rooms.
• Recognize and report out-of-specification or unexpected results due to environmental impacts.
• Reading and verification of plates.
• Perform daily instrument verifications as required.
• Communicate results clearly and accurately in documentation.
• Record and report results of analysis per lab procedures and systems.
• Maintain clean and organized work area and equipment.
• Comply with SOPs, GMP, GLP, ALCOA, audits and safety guidelines.
• Maintain required training and compliance status.
• Perform other duties as assigned.

Skills

Attention to detail

Problem solving

Communication

Independent worker

Education

Bachelor's degree in Chemistry, Biology, Biochemistry or related field

Tools

HPLC

GC

Spectroscopy

Dissolution testing

Wet chemistry

Job description

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), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.)

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.

DESCRIPTION: Join us at Thermo Fisher Scientific as a QC Scientist I to contribute to global health through quality control testing that ensures the safety and efficacy of pharmaceutical products. You will perform Environmental Monitoring tasks in support of Steriles production within classified areas. The individual is encouraged to follow the 4i Values that are held in high regards by the company when completing their work. The four values are integrity, innovation, intensity, and involvement. The job function includes aseptic technique which requires the individual to gain knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured. Typical shift hours are 6pm-6am on a 2-2-3 rotating schedule.

Key Responsibilities

• Execute validated environmental test methods for routine environmental monitoring in clean rooms (i.e. classified areas and aseptic processing).
• Recognize and report out-of-specification or unexpected results due to environmental impacts or other to reach resolution.
• Reading and verification of plates.
• Perform daily instrument verifications as required.
• Clearly and accurately communicate the results of work by creating documentation of the testing/analysis and obtained results.
• Record and report results of analysis in accordance with prescribed lab procedures and systems.
• Cleans and organizes work area, instrumentation/equipment, and testing materials.
• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, ALCOA, Audits and Safety guidelines.
• Maintain the necessary training, compliance status required by company and facility standards.
• And other duties as assigned.

REQUIREMENTS

• Bachelor's degree required, no prior experience required
• Preferred Fields of Study: Chemistry, Biology, Biochemistry or related scientific field
• Proficiency with analytical techniques including HPLC, GC, spectroscopy, dissolution testing, and wet chemistry methods
• Experience with microbiological testing, environmental monitoring, and aseptic techniques
• Knowledge of GMP regulations, documentation practices, and pharmaceutical quality standards
• Strong attention to detail with ability to follow standard procedures and maintain data integrity
• Excellent problem-solving skills and logical approach to scientific challenges
• Proficient computer skills including Microsoft Office and laboratory information systems
• Strong written and verbal communication abilities
• Ability to work both independently and collaboratively in a dynamic environment
• Physical requirements include standing/walking for extended periods, lifting up to 50 lbs, and manual dexterity
• Must be able to work in cleanroom environments wearing required PPE
• Ability to work various shifts including nights, weekends, and holidays as needed
• Experience in pharmaceutical/regulated environment preferred but not required