Specialist Quality Control - 02

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

For QC Services in the Laboratory area. FITS is looking for a QC Microbiology Specialist to support a leading biotechnology manufacturer. You’ll be the technical specialist for microbiology and molecular biology testing. You’ll write method validation reports for new products, troubleshoot assays, approve lab investigations, and lead technical work across sites and teams. If you know microbiology testing inside out and like solving complex problems with data, this role is for you.

What Makes You A Fit:

• One of the following:
  • a Doctorate,
  • a Master’s plus 2+ years of directly related experience, or
  • a Bachelor’s plus 4+ years of directly related experience
• Shift: Administrative, and according to business needs.
• Experience leading audit teams or interacting with regulatory agencies is a plus

Preferred Qualifications:

• Background in Microbiology, with technical writing experience for Microbial Method Validation (MMV) reports for new product introductions.
• Knowledge of Bioburden, Endotoxin, Low Endotoxin Recovery (LER), Sterility, and Mycoplasma testing.
• Experience giving technical support to a microbiology lab, including designing special studies.
• Experience supporting deviation owners with event evaluations and root cause analysis.

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Give technical guidance, reports, and data analysis, and keep communication flowing between technical groups until issues are resolved
• Troubleshoot assays and resolve technical issues
• Keep the lab compliant by putting procedures in place that strengthen GMP, GLP, and safety
• Manage current programs, processes, and methods, and develop and roll out new ones
• Write, revise, and audit complex controlled documents that affect multiple sites or organizations
• Approve lab investigations and lead audit teams
• Serve as subject matter expert and develop technical training
• Represent the department on teams and follow through on action items across sites on your own
• Work with regulatory agencies on your areas of responsibility, including written responses
• Resolve issues with outside resources and vendors
• Perform routine testing in your area when needed and take on special projects
• Supervise employees when needed to meet technical requirements
• Handle multiple projects at once, shift priorities, and lead and influence cross-functional teams, communicating clearly in writing and verbally.

Being a FITS Piece Comes With Perks

• Work on high-impact projects with one of Puerto Rico’s top biotechnology manufacturers
• Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices

Who We Are

FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a match that lasts.

Are you the next piece?