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Specialist QA - 35382

  • Juncos, PR
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary
We are seeking a highly motivated Specialist QA to support Quality Operations through advanced data analysis, statistical evaluation, and trending of quality-related information within a GMP-regulated environment. The successful candidate will be responsible for transforming complex datasets into meaningful insights, identifying emerging trends, assessing potential risks, and providing data-driven recommendations to support quality and operational decisions.
This role requires strong analytical thinking, advanced statistical knowledge, technical writing skills, and the ability to exercise sound judgment when evaluating events or situations that may not be specifically addressed in established procedures. The Specialist QA will collaborate cross-functionally to drive continuous improvement initiatives and ensure quality decisions are supported by objective data analysis.

Key Responsibilities

Data Analytics & Trending
  • Develop, maintain, and continuously improve quality data trending and monitoring processes.
  • Analyze large datasets from multiple quality systems to identify trends, patterns, risks, and opportunities for improvement.
  • Perform statistical analyses and data interpretation using tools such as Excel, Minitab, Spotfire, and other analytics platforms.
  • Create dashboards, reports, and visualizations to effectively communicate quality performance metrics and emerging trends.
  • Generate routine and ad hoc trend reports for Quality, Operations, and Site Leadership.
  • Evaluate data to identify adverse trends, anomalies, recurring issues, and process variability.
  • Provide scientifically sound and data-driven recommendations to support decision-making processes.
Technical Writing & Communication
  • Prepare technical reports, trend analyses, executive summaries, and data-driven assessments.
  • Translate complex statistical findings into clear and actionable recommendations for stakeholders at all organizational levels.
  • Present data analyses and conclusions effectively to Quality, Operations, and Senior Management.
  • Author and review quality documentation related to trending methodologies, statistical evaluations, and data governance practices.
Digital & Analytical Tools
  • Utilize advanced Microsoft Excel capabilities, including complex formulas, pivot tables, Power Query, dashboards, and data visualization techniques.
  • Apply statistical methods using Minitab or equivalent software to support process monitoring and decision-making.
  • Leverage electronic quality systems and data platforms such as Veeva, Spotfire, LIMS, Maximo, Smartsheet, and similar applications.
  • Incorporate data analytics and artificial intelligence tools when appropriate to enhance analysis efficiency and insight generation.
Quality Systems Support
  • Support investigations, deviations, CAPAs, change controls, and other quality system processes through data analysis and statistical assessments.
  • Participate in risk assessments and provide analytical justification for quality decisions.
  • Assess quality events and recommend actions based on data, trends, historical performance, and risk evaluation.
  • Support Management Review meetings and quality governance forums by presenting analytical findings and recommendations.
  • Collaborate with cross-functional teams to identify root causes, improvement opportunities, and preventive measures.
  • Support Continuous Improvement initiatives through quantitative analysis and performance monitoring.
  • Ensure consistency, accuracy, and integrity of quality-related data.
Minimum Requirements
Doctorate degree OR
Master’s degree + 2 years of directly related experience OR
Bachelor’s degree + 4 years of directly related experience
Preferred Qualifications
Academic background in Microbiology, Biology, or Life Sciences

Knowledge & Skills
  • Environmental Monitoring (EM), Microbial Identification (Micro ID), and Critical Utilities monitoring
  • Sampling techniques and equipment for monitoring programs
  • Data trending, analysis, and evaluation
  • Microbiological testing methods for cleanrooms and controlled environments
  • Aseptic behavior and contamination control practices
  • Facility cleaning and disinfection procedures
  • Familiarity with regulatory standards: Annex 1, FDA Guidance, ISO 14644-1, USP
  • Proficiente in word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel)
  • Experience with data visualization and statistical tools
  • 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.
  • Exposure to AI tools, including data analytics and large language models
  • Strong communication, facilitation, and presentation skills
  • Fully bilingual: English and Spanish (written and oral)
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.