Senior QA Specialist - Validation & Compliance Lead

QRC Group, LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QRC Group, LLC is seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs and lead QA initiatives at the site.

The role requires extensive experience in validation, risk management, and regulatory documentation, with involvement in NPI, incident triage, and continuous improvement of quality systems. On-site position based in Puerto Rico.

Qualifications

• Requires Doctorate with 2+ years related experience or Masters with 4+ years, or Bachelors with 6+ years, or Associates with 10+ years, or High school/GED with 12+ years.
• Experience in facilities and utilities commissioning and qualification.
• Experience with Computer System Validation and equipment validation.
• Familiar with risk assessments and data integrity.
• Knowledge of GxP documentation and change controls.
• Experience with SOPs and documents revision and approval.
• Experience with syringe/vials inspection processes.

Responsibilities

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

Skills

Quality Assurance

Data Integrity

Risk Management

Change Controls

SOPs

Documentation Practices

Decision Making Techniques

Education

Doctorate

Masters

Bachelors

Associates

High School

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

Job description

QRC Group, LLC is seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs and lead QA initiatives at the site.

The role requires extensive experience in validation, risk management, and regulatory documentation, with involvement in NPI, incident triage, and continuous improvement of quality systems. On-site position based in Puerto Rico.