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Inteldot

Sr. Specialist QA 35712

Inteldot Juncos, Puerto Rico

IT Services and IT Consulting · 11-50 employees

Yesterday
qa Senior (5-10 yrs) Full-time Puerto Rico
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About the role

The role involves acting as a technical specialist for the Quality Assurance program, including reviewing product MPs and ensuring site-level compliance. The specialist will lead investigations, manage quality systems, and collaborate across functions to ensure manufacturing processes meet regulatory standards.

What they look for

Quality Assurance Equipment Validation Commissioning Qualification Change Controls SOPs Process Validation Regulatory Compliance Root Cause Analysis Incident Management Data Analysis Technical Documentation Project Management Stakeholder Management Manufacturing Processes Quality Systems

Requirements

Candidates must have experience in equipment validation, commissioning, and quality systems within a regulated environment. Educational requirements range from a Doctorate with 2 years of experience to a High school diploma with 12 years of experience.

Full description

Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift

Job Description:

In support of site's Quality Assurance program acts as the technical specialist. Review and approve product MPs.

Requirements:

  • Experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP’s

Responsibilities:

Quality Assurance & Compliance The role requires strong ownership of site-level quality activities, including quality systems, compliance assessments, investigations, incident management, and quality decision-making. The individual must be capable of making sound quality judgments and ensuring that manufacturing activities remain compliant with applicable requirements.

Validation & Manufacturing Knowledge A strong technical understanding of manufacturing processes, process validation, sanitary utilities, environmental characterization, validation activities, and process development is essential. The role requires the ability to review technical documentation and determine whether processes and systems meet established quality and regulatory expectations.

Investigation & Problem Solving The position requires experience leading investigations and evaluating incidents from a quality perspective. This includes identifying potential compliance or product-quality concerns, coordinating appropriate stakeholders, determining root causes, and ensuring effective follow-up and resolution.

Cross-Functional Leadership The individual must be comfortable leading and influencing teams without necessarily having direct authority. Strong collaboration, negotiation, communication, and stakeholder-management skills are important, particularly when working with Manufacturing, Engineering, Validation, Regulatory, Supply Chain, and other functions.

Project & Organizational Management Strong project-management capabilities are expected, including the ability to prioritize multiple assignments, coordinate deliverables, manage timelines, and ensure commitments are completed. Attention to detail and follow-through are particularly important in a highly regulated environment.

Regulatory & Inspection Readiness The role requires familiarity with regulatory expectations and the ability to interact professionally with regulatory agencies. This suggests the person should be comfortable explaining quality decisions, presenting documentation, and supporting regulatory interactions or inspections.

Data Analysis & Quality Decision-Making Advanced capability in data trending, analysis, and interpretation is important. The individual should be able to identify trends, assess potential quality risks, evaluate compliance gaps, and use data to support appropriate quality decisions.

Technical & Business Tools The position requires strong proficiency with standard business and quality-related software, particularly for data analysis, spreadsheets, presentations, databases, and technical documentation.

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

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