Microbiology QC Lead — GMP/GLP Expert

FITS LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Work on high-impact projects

Grow career across FITS’ network of bi

Job summary

FITS LLC in Puerto Rico seeks a QC Microbiology Specialist to support a leading biotechnology manufacturer. You will be the technical specialist for microbiology and molecular biology testing, write method validation reports, troubleshoot assays, approve lab investigations, and lead technical work across sites and teams.

You will provide guidance, develop training, and communicate across groups to resolve issues while maintaining GMP/GLP compliance and safety.

Qualifications

• Doctorate, Master’s + 2+ years of directly related experience, or Bachelor’s + 4+ years of directly related experience are required.
• Experience leading audit teams or interacting with regulatory agencies is a plus.
• Background in Microbiology with experience writing MMV reports for new product introductions is preferred.

Responsibilities

• Provide technical guidance, reports, and data analysis and ensure cross-team communication until issues are resolved.
• Troubleshoot assays and resolve technical issues.
• Keep the lab compliant by strengthening GMP, GLP, and safety procedures.

Skills

GMP/GLP understanding

Technical writing

Auditing experience

Regulatory liaison

Education

Doctorate

Master’s + 2+ years of experience

Bachelor’s + 4+ years of experience

Job description

FITS LLC in Puerto Rico seeks a QC Microbiology Specialist to support a leading biotechnology manufacturer. You will be the technical specialist for microbiology and molecular biology testing, write method validation reports, troubleshoot assays, approve lab investigations, and lead technical work across sites and teams.

You will provide guidance, develop training, and communicate across groups to resolve issues while maintaining GMP/GLP compliance and safety.