Sr. Specialist QA 35712

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 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