Specialist QA

QRC Group, LLC•Juncos, PR

About The Position

Specialist QA with experience in regulated industry and 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. Proficient in word processing, presentation, database, and spreadsheet applications (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 such as Documentation platforms (Veeva, Spotfire, LIMS, Maximo). Experience with artificial intelligence tools like data analytics and large language models. Strong communication (both written and oral), facilitation, and presentation skills. Fully Bilingual in English and Spanish.

Requirements

Doctorate or Master's Degree and 2 years of experience or Bachelor's Degree and 4 years of experience or Associate Degree and 8 years of experience (Educational background: Microbiology, Biology of Life Sciences).
Expertise in CAPA, Quality Assurance, NPI and Characterization Process.
Bilingual (English and Spanish).

Nice To Haves

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 oral), facilitation and presentation skills.
Fully Bilingual in English and Spanish.

Responsibilities

Supports the 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 from the Environmental Control perspective.
Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.
Attends 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.