New · posted Nov 8
Thermo Fisher Scientific · Pharmaceuticals
QC Scientist II - Microbiology
- Greenville, NC
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
What you need
- 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 QUALIFICATIONSnice to have
- 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.
What you'll do
- 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.
Where you'll work
Greenville, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Greenville, NCWorking conditions
First Shift (Days)
Environmental Conditions
Laboratory Setting
- 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.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $90,500 | $106,500 | $119,500 |
Comparisons: the base pay employers published on open Microbiology & Sterility Assurance roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Microbiology & Sterility Assurance
The general path across 57 open Microbiology & Sterility Assurance roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods12
- Collaboration and leadership6
- GMP and compliance4
- Documentation and SOPs4
- Investigations and CAPA3
- Quality systems and risk2
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Microbiology & Sterility Assurance work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validationNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 118
- Open roles
- 118
- Distinct roles
- 51
- Locations
By discipline
- Quality74 60%
- Clinical43 35%
- Regulatory6 5%
By level
- Senior & Principal56 46%
- Associate & Specialist36 29%
- Manager25 20%
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QC Scientist II - Microbiology at Thermo Fisher
Open until filled.