Senior QC Microbiology Analyst (EM & Micro)

Forge Biologics; Columbus (OH); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid parental leave

Annual bonus opportunities

Onsite fitness facility

Job summary

Forge Biologics in Columbus, Ohio is seeking a Senior Analyst, Quality Control (EM & Micro) on 2nd shift to lead EM testing and microbiology activities. The role emphasizes SME responsibilities, SOP development, and collaboration across QC and cross-functional teams.

The candidate will supervise testing, CAPAs, deviations and may mentor junior analysts while supporting regulatory inspections and internal audits. The environment offers growth, mentorship, and a commitment to patient impact.

Qualifications

• Bachelor’s degree in microbiology, biology or related field is required.
• Minimum 4 years of GMP-regulated QC or EM experience including Microbiology lab.
• Proficiency in microbiology techniques: Bioburden, Endotoxin, Sterility, Growth Promotion.
• Experience with Environmental Monitoring and clean room sampling.
• Familiarity with EMPQ protocols, risk assessments and CAPA processes.
• Experience drafting SOPs, change controls and lab investigations using Veeva Vault/TrackWise.

Responsibilities

• Serve as SME for EM and Microbiology testing and method enhancements.
• Manage testing timelines, execution, and results for growth promotion and sterility.
• Write and implement SOPs, work instructions, and QC protocols per cGMP.
• Oversee QC buffer testing and results entry into databases.
• Lead investigations, deviations, change controls, CAPAs timely.
• Mentor junior analysts and provide technical guidance.

Skills

EM testing

Microbiology

SOP writing

CAPA

GMP knowledge

Training/mentoring

Education

Bachelor’s degree in microbiology or related field

Tools

JMP

LIMS

NetSuite

Veeva Vault

TrackWise

Job description

Forge Biologics in Columbus, Ohio is seeking a Senior Analyst, Quality Control (EM & Micro) on 2nd shift to lead EM testing and microbiology activities. The role emphasizes SME responsibilities, SOP development, and collaboration across QC and cross-functional teams.

The candidate will supervise testing, CAPAs, deviations and may mentor junior analysts while supporting regulatory inspections and internal audits. The environment offers growth, mentorship, and a commitment to patient impact.