The Quality Assurance Specialist – Utilities & Environmental Monitoring is responsible for performing GMP-compliant sampling collection and quality monitoring oversight of the Site Utilities Systems and Environmental Monitoring (EM) Program. This role supports the QA team in ensuring the ongoing compliance, performance reporting, and inspection readiness of site utility systems and classified environments in accordance with FDA regulations, ISPE guidelines, and internal quality standards.

Sampling Collection & Environmental Monitoring

• Perform sample collection and quality monitoring oversight of Site Utilities Systems (e.g., water systems, steam, compressed gases) and the Environmental Monitoring Program (e.g., room air – viable and non-viable, contact plates).
  

• Ensure timely sample collections in accordance with the applicable sampling plan or protocol and in compliance with procedural requirements.
  

• Support QA oversight of Site Utilities Systems and Environmental Monitoring results.
  

• Coordinate with impacted areas including the laboratory, utilities, and manufacturing operations.
  

• Ensure appropriate and correct use of applicable equipment for sample collection and delivery.
  

• Apply and assure appropriate aseptic techniques during all sampling activities.
  

• Ensure timely approval and reporting of applicable sampling results.
  

• Maintain appropriate documentation in compliance with Good Documentation Practices (GDP) and data integrity requirements.

Quality Oversight & Compliance

• Provide Quality Assurance oversight to GMP manufacturing operations.
  

• Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
  

• Serve as a reviewer of GMP and quality-related SOPs, as applicable.
  

• Provide QA assistance and feedback to utilities and operational staff.

Inspection Readiness & Continuous Improvement

• Support the execution of inspection readiness activities, including participation in self-inspection activities when required.
  

• Maintain quality systems and proactively suggest process improvements.
  

• Escalate quality issues to the site-based process team in a timely manner.

Education

• Bachelor’s Degree (minimum) in a science, engineering, or pharmaceutical-related field.

Experience

• One (1) to three (3) years of experience in a GMP- and FDA-regulated environment in roles such as Quality Assurance, Quality Control Laboratory, Manufacturing, or Technical Services.

Technical Competencies

• Proficiency with computer systems including Microsoft Office Suite, TrackWise, SAP, DARWIN, Veeva Quality Docs (QDocs), Building Management Systems (BMS), and other Quality Systems platforms.
  

• Knowledge and application of Good Documentation Practices (GDP) and data integrity principles.
  

• Demonstrated capability to perform and critically evaluate Aseptic Techniques.
  

• Understanding of GMP regulatory requirements applicable to pharmaceutical manufacturing environments.

Core Competencies & Behavioral Expectations

• Establishes positive interpersonal relationships and interacts effectively with internal and external stakeholders at all organizational levels.
  

• Organizes and prioritizes multi-functional tasks in a dynamic, time-sensitive environment.
  

• Exercises sound judgment and demonstrate assertiveness when required.
  

• Works effectively under minimal supervision with a high degree of accountability.
  

• Demonstrates excellent decision-making capability.
  

• Demonstrates teamwork by collaborating cross-functionally across all organizational levels.
  

• Supports continuous improvement initiatives and drives productive working relationships.

Additional Requirements

• Bilingual (English and Spanish) with strong verbal and written communication skills required.
  

• Ability to travel within and outside Puerto Rico and the United States as needed.
  

• Flexibility to support a 24/7 operation, including irregular hours, shift rotations, weekends, holidays, and emergency situations.
  

• Capability to work as a resource in other business areas depending on operational needs.

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