Specialist QA

Cencora•Juncos, PR

5h•Onsite

About The Position

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. 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 form 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.

Requirements

Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Values/Leadership Practices.

Nice To Haves

Microbiology, Biology or Life Sciences
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 form 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.