JT382 - SPECIALIST QA

Quality Consulting Group•Juncos, PR

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

Bachelor’s degree in Microbiology, Biology or Life Sciences
4+ years of directly related QA experience in a regulated manufacturing environment
Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring
Knowledge of Sampling monitoring: equipment and techniques
Data trending and evaluation experience
Microbiological testing methods and standards for clean rooms and controlled environments
Knowledge in Aseptic behavior in manufacturing areas to prevent contamination
Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP
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 oral), facilitation and presentation skills.
Fully Bilingual in English and Spanish.

Responsibilities

Supports the client's site GMP buildings Environmental Monitoring Process.
Generates Environmental Monitoring and Critical Utilities trend reports.
Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas.
Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control perspective.
Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.
Attends client's GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation.
Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
Supports Continuous Improvement initiatives, programs, and projects.
Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures.
Alerts senior management of quality, compliance, supply, and safety risks.
Supports internal/external audits and inspections as needed.