Sr. Specialist QA 35711

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:

• Facilities and Utilities Commissioning and Qualification, Computer System Validation, Equipment validation, Risk Assessments & Management
• Softwares: KNEAT, CDOCS, SCADA, TRACKWISE, MAXIMO
• Good Documentation Practices, Data Integrity, Change Controls, Standard Operation Procedure
• Experience with Syringe/Vials Inspection Process
• Documents revision and approval
• Strong knowledge in Decision Making Techniques

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