QC Microbiology Scientist II – GMP & Microbial ID

NCBioImpact; Greenville (NC); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP knowledge

Microbiology testing

MALDI-TOF / MicroSeq

Data review & documentation

Technical mentoring

Formation

Bachelor's degree in Biology / Microbiology

Advanced degree (MS/PhD) in related field

Outils

LIMS

Microsoft Office

Description du poste

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.