Senior QA Specialist — Validation & Compliance Leader

Inteldot; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot is seeking an Administrative Shift QA specialist to support the site’s Quality Assurance program. You will review and approve product MPs and ensure compliance with regulatory standards in Puerto Rico.

The role emphasizes ownership of quality activities, investigations, and data-driven decisions, with collaboration across Manufacturing, Engineering, Validation, and Regulatory teams to maintain compliant operations.

Qualifications

• Experience in Commissioning, Qualification, and equipment validation.
• Familiar with GMP/GxP and Change Controls.
• Strong data analysis and quality decision-making.
• Experience leading investigations and root cause analysis.
• Comfortable cross-functional leadership in regulated environments.
• Ability to interact with regulatory agencies.

Responsibilities

• Own site-level quality activities and QA systems.
• Review manufacturing validation and process docs.
• Lead investigations and determine root causes.
• Collaborate with Manufacturing, Validation, Regulatory, and others.
• Manage multiple quality projects with timelines.
• Prepare for regulatory inspections and firm documentation.
• Analyze data trends to guide quality decisions.
• Utilize quality software and data tools for reporting.

Skills

Commissioning

Qualification

Equipment validation

QRAES

Kneat

Good Documentation Practices

Change Controls

SOPs

Education

Doctorate + 2 years of directly related experience

Masters + 4 years of directly related experience

Bachelors + 6 years of directly related experience

Associates + 10 years of directly related experience

High school/GED + 12 years of directly related experience

Tools

Data analysis software

Spreadsheets

Presentations

Databases

Technical documentation

Job description

Inteldot is seeking an Administrative Shift QA specialist to support the site’s Quality Assurance program. You will review and approve product MPs and ensure compliance with regulatory standards in Puerto Rico.

The role emphasizes ownership of quality activities, investigations, and data-driven decisions, with collaboration across Manufacturing, Engineering, Validation, and Regulatory teams to maintain compliant operations.