Sr Specialist QA

QRC Group; Juncos (PR); On-site; USD 95,000 - 125,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico seeks a Sr. Specialist QA to support quality assurance programs and act as the technical specialist. Review and approve product MPs.

The role involves leading investigations, owning site quality procedures, and representing Quality on incident triage teams. Strong background in validation, GMP-like controls, and data integrity is required.

Qualifications

• Advanced knowledge of quality systems and GMP compliance.
• Experience approving process validation protocols and reports.
• Strong documentation and data integrity practices.
• Ability to lead investigations and incident triage.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality on incident triage team.
• Release of sanitary utility systems.
• Approve planned incidents.
• Lead investigations.
• Own site quality program procedures.

Skills

Decision making techniques

Good Documentation Practices

Data Integrity

Change Controls

SOP

Education

Doctorate + 2 years

Masters + 4 years

Bachelors + 6 years

Associates + 10 years

High school/GED + 12 years

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

Job description

Juncos, Puerto Rico | Posted on 09/15/2026

We are seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs.

FUNCTIONS

- Approve process validation protocols and reports for mfg. processes.

- Represent Quality on incident triage team.

- Release of sanitary utility systems.

- Approve planned incidents.

- Lead investigations.

- Own site quality program procedures.

Requirements

Education:Doctorate + 2 years of directly related experience or Masters + 4 years of directly related experience or Bachelors + 6 years of directly related experience or Associates + 10 years of directly related experience or High school/GED + 12 years of directly related experience.

Experience with:

• Facilities and Utilities Commissioning and Qualification
  
• Computer System Validation
  
• KNEAT,CDOCS, SCADA, TRACKWISE,MAXIMO
  
• Good Documentation Practices, Data Integrity
  
• Change Controls
  
• Standard Operation Procedure
  
• Documents revision and approval
  
• Strong knowledge of Decision Making Techniques