QC Scientist II - Microbiology

Thermo Fisher Scientific • Greenville, NC

2d • Onsite

About The Position

Join Thermo Fisher Scientific as a QC Scientist II – Microbiology, supporting pharmaceutical manufacturing operations at the Greenville, NC facility. The role performs microbiological testing of raw materials, incoming components, and finished oral solid dosage (OSD) products while ensuring compliance with Good Manufacturing Practices (GMP). It includes compendial microbiological testing, analytical data review, troubleshooting, and support for laboratory investigations and continuous improvement. The scientist contributes to technical documentation, mentors junior staff, and helps ensure product quality and patient safety within a collaborative Quality Control team.

Requirements

• Advanced degree plus 1 year of experience, or a bachelor's degree plus 3 years of experience in GMP pharmaceutical/biopharmaceutical quality control.
• Degree field in Biology, Microbiology, or a related scientific discipline.
• Hands-on experience with compendial microbiological testing, including USP <61>/<62>, microbial identification using MALDI-TOF/MicroSeq, and growth promotion testing.
• Strong understanding of GMP requirements, technical documentation, data review, and laboratory troubleshooting.
• Excellent attention to detail, analytical thinking, and problem-solving skills.

Nice To Haves

• Knowledge of FDA/EMA regulatory guidance and experience with quality investigations and CAPAs.
• Experience with LIMS, data analysis, and Microsoft Office.
• Strong technical writing, organizational, and communication skills.
• Ability to work independently and collaboratively across teams.
• Experience mentoring or providing technical guidance to laboratory personnel.

Responsibilities

• Perform and review microbiological testing for product release and stability, including USP <61>/<62>, microbial identification, and growth promotion testing.
• Conduct microbial identification using MALDI-TOF and/or MicroSeq instrumentation.
• Support raw material, component, finished product, and environmental monitoring testing.
• Review laboratory data and author or revise SOPs, technical reports, and GMP documentation.
• Troubleshoot laboratory issues and participate in investigations, root cause analysis, and CAPAs.
• Collaborate with cross-functional teams, provide technical guidance to junior staff, and support continuous improvement.
• Interface with clients and regulatory authorities as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level