QC Deviation Specialist: Root-Cause & CAPA Lead (GMP)

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

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.