QC Scientist II - Microbiology

NCBioImpact; Greenville (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific in Greenville, NC invites applications for a QC Scientist II – Microbiology. You will perform microbiological testing on raw materials, in-process and finished products, adhering to GMP and regulatory standards.

The role includes data review, SOP maintenance, and mentoring junior staff while supporting CAPA investigations and cross-functional collaboration within a quality-focused team.

Qualifications

• Requires GMP pharmaceutical/biopharmaceutical quality control experience.
• Experience with compendial microbiological testing (USP <61>/<62>).
• Strong documentation and data-review skills.

Responsibilities

• Perform and review microbiological testing for product release and stability.
• Conduct microbial identification using MALDI-TOF and MicroSeq.
• Support raw material, component, finished product, and environmental monitoring testing.
• Review laboratory data and author/revise SOPs, technical reports, and GMP documentation.
• Troubleshoot laboratory issues and participate in investigations and CAPAs.
• Collaborate with cross-functional teams and mentor junior staff.
• Interface with clients and regulatory authorities as needed.

Skills

GMP knowledge

Microbiology testing

MALDI-TOF / MicroSeq

Data review & documentation

Technical mentoring

Education

Bachelor's degree in Biology / Microbiology

Advanced degree (MS/PhD) in related field

Tools

LIMS

Microsoft Office

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Laboratory Setting

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.

QC Scientist II – Microbiology

Location:

Greenville, NC

DESCRIPTION

Join Thermo Fisher Scientific as a QC Scientist II – Microbiology, supporting pharmaceutical manufacturing operations at our Greenville, NC facility. In this role, you'll perform microbiological testing of raw materials, incoming components, and finished oral solid dosage (OSD) products while ensuring compliance with Good Manufacturing Practices (GMP).

You'll conduct compendial microbiological testing, review analytical data, troubleshoot technical issues, and support laboratory investigations and continuous improvement initiatives. Working within a collaborative Quality Control team, you'll also contribute to technical documentation, mentor junior staff, and help ensure product quality and patient safety.

KEY 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/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.

REQUIREMENTS

• Advanced degree plus 1 year of experience, or bachelor's degree plus 3 years of experience in GMP pharmaceutical/biopharmaceutical quality control.
• Preferred fields of study: Biology, Microbiology, or related scientific discipline.
• Hands-on experience with compendial microbiological testing, including USP <61>/<62>, microbial identification (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.

PREFERRED QUALIFICATIONS

• 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.

WORK ENVIRONMENT

• Onsite laboratory position requiring PPE and adherence to safety procedures.
• Weekend or flexible scheduling may be required.
• Physical requirements include standing, manual dexterity, and lifting up to 25 lbs.