Senior QA Specialist: Validation & Compliance Lead

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a highly motivated QA professional to join our team in a world-class manufacturing environment in Puerto Rico and the USA. You will oversee process validation, QA representation on incident triage and NPI teams, and drive investigation-led improvements across site quality programs.

Ideal candidates bring 6+ years of relevant experience, strong regulatory interaction skills, and a track record of equipment validation, QRAES, Kneat, Change Controls, and

Qualifications

• Bachelor's degree in a related area required.
• 6 years of directly related experience.
• Experience in commissioning and qualification, equipment validation, QRAES, Kneat, GxP documentation, Change Controls, and SOPs.
• Strong organizational skills and ability to follow assignments through to completion.
• Experience interacting with regulatory agencies.
• Excellent written and verbal communication, and data evaluation abilities.

Responsibilities

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

Skills

Project management

Organizational skills

Communication

Data trending & analysis

Regulatory interaction

Education

Bachelor's degree in related area

Tools

Kneat

QRAES

Change controls

Job description

Quality Consulting Group, LLC is seeking a highly motivated QA professional to join our team in a world-class manufacturing environment in Puerto Rico and the USA. You will oversee process validation, QA representation on incident triage and NPI teams, and drive investigation-led improvements across site quality programs.

Ideal candidates bring 6+ years of relevant experience, strong regulatory interaction skills, and a track record of equipment validation, QRAES, Kneat, Change Controls, and