Specialist Quality Control

Flexible & Integrated Technical Services, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Work on high-impact projects

Career growth across FITS network

Job summary

FITS LLC in Puerto Rico is seeking a QC Deviation Specialist to own deviations in the Quality Control lab, investigating events, identifying root causes, and ensuring corrective actions are effective across sites.

We value microbiology knowledge, hands-on HPLC experience, and GMP/GDP data review skills. The role emphasizes cross-functional teamwork, regulatory communication, and driving CAPAs to completion.

Qualifications

• Experience handling deviations in QC area including investigations, root cause analysis and CAPAs.
• Background in Microbiology.
• Hands-on experience with HPLC.
• Knowledge of analytical methods and lab data review under GMP and GDP.

Responsibilities

• 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.

Skills

TrackWise experience

Microbiology background

HPLC experience

GMP/GDP data review

Education

Doctorate

Master’s + 2+ years related experience

Bachelor’s + 4+ years related experience

Job description

For QC Services in the Laboratory area.

FITS is looking for a QC Deviation Specialist to support a leading biotechnology manufacturer. You’ll own deviations in the Quality Control lab: investigating events, finding root causes, and making sure the corrective actions stick. If you have a sharp eye for lab data and like getting to the “why” behind an event, 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 with TrackWise or a similar quality management system is a plus

Preferred Qualifications:

• Experience handling deviations in a Quality Control area, including investigations, root cause analysis, and CAPAs
• Background in Microbiology
• Hands-on experience with HPLC
• Knowledge of analytical methods and lab data review under GMP and GDP

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?