Specialist QA 35382

Inteldot; Juncos (PR); On-site; USD 42,000 - 62,000; Full time

Job summary

Inteldot is seeking an Administrative Shift role focusing on Quality Assurance within a pharmaceutical manufacturing environment in Puerto Rico. The candidate will support the QA program across manufacturing, process validation, and regulatory compliance, contributing to a compliant, data-driven environment.

Responsibilities include handling environmental monitoring data, trend analysis, and maintaining documentation in electronic systems with cross-functional collaboration.

Qualifications

• Experience in environmental monitoring and microbial testing.
• Knowledge of regulatory requirements: Annex 1, FDA Guidance, ISO-14644-1, USP.
• Proficient with Smartsheets and MS Office; able to visualize and report data.

Responsibilities

• Support QA program in manufacturing, process validation, regulatory compliance, and QA activities.
• Analyze environmental monitoring data and report trends.
• Assist in documentation using electronic systems.
• Collaborate with cross-functional teams and present findings.

Skills

Environmental Monitoring

Microbial ID

Data Trending

Aseptic Techniques

Regulatory Knowledge

English/Spanish

Statistical Tools

LIMS/Maximo/Veeva

MS Office

Education

Doctorate (PhD)

Masters + 2y exp

Bachelor's + 4y exp

Associates + 8y exp

High school/GED + 10y exp

Microbiology/Life Sciences

Tools

Smartsheets

Microsoft Office

Veeva

Spotfire

LIMS

Maximo

Job description

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Requirements & Qualifications:

Knowledge in:

• Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring


• Sampling monitoring: equipment and techniques


• Data trending and evaluation


• Microbiological testing methods and standards for clean rooms and controlled environments


• Aseptic behavior in manufacturing areas to prevent contamination


• Facility cleaning and disinfection


• Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP


• Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel)


• Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data


• Ability to analyze trend reports and environmental/CU data to identify areas for improvement


• Hands on experience in electronic systems for instance: Documentation platforms such as Veeva, Spotfire, LIMS, Maximo.


• Use of artificial intelligence tools such as data analytics and large language models


• Strong communication (both written and verbal), facilitation and presentation skills.


• Fully Bilingual in English and Spanish

Education

• Doctorate OR Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience


• Preferred: Microbiology, Biology or Life Sciences