Posted August 10, 2026
Quality Assurance Analyst
Kelly Services
00617, PR, US
Full Time
Job Description
Job Description
At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one?
We’re seeking an Quality Assurance Analyst to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, it’s all about finding the job that’s just right
Purpose:
Describes the primary goals, objective or function or outputs of this position.
Provide leadership and direction in all aspects of quality processes that manage nonconformance and CAPA, Change Control and Risk Management.
Responsibilities:
Monitor performance through appropriate Key Performance Indicators (KPIs) for CAPA, Change Control, and Risk Management. Ensure a timely completion of actions identified in: Exception Reporting System, Change Management or Risk Management quality records and programs.
Provide leadership to ensure that actions are properly reviewed in order to ensure appropriate definition and timely completion of actions and review of significant trends/issues to prevent regulatory liabilities and financial losses. Evaluate if actions were effective and verified after implementation. Confirm that actions do not adversely affect the finished product.
Maintain the required databases necessary for tracking and trending to ensure actions are implemented and documented.
Facilitate meetings to ensure timely identification and management of events, including but not limited to triage and CAPA review board. Drive dialogue and discussion to ensure non-conformances are appropriately documented in a timely manner and that - when required - investigations are timely, rigorous and drive to root cause to facilitate the identification and implementation of effective corrections, corrective and preventive actions.
Provide in a timely manner information and analysis required for the Annual Quality Reviews, among other meetings.
Review and perform statistical analysis of all exception documents by reasons (re-inspections, NCR, Deviations and associated formal investigations). Correlate information and summarize it with the corresponding corrective actions. Identify if there are trends indicating the need for changes manufacturing or control procedures.
Experience Requirements:
This position requires knowledge in: quality / compliance management, visual inspection AQL and operator certification processes, aseptic processing operations, as well as regulations and standards affecting Biologics and Parenteral applications.
Qualifications :
Bachelor’s degree in Natural Sciences, preferably Biology, Chemistry or related field.
Experience in a Quality or technical field in the Pharmaceutical or Biotechnological industry preferred.
Quality/compliance management skills as well as regulations and standards.
Position requires computer literacy to manage multiple computer programs and databases.
Knowledge of data processing system, analytical competence, good verbal and written communication skills in both languages, English and Spanish.
Prior experience in CAPA, Change Control, and/or Risk Management is preferred.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
We’re seeking an Quality Assurance Analyst to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, it’s all about finding the job that’s just right
Purpose:
Describes the primary goals, objective or function or outputs of this position.
Provide leadership and direction in all aspects of quality processes that manage nonconformance and CAPA, Change Control and Risk Management.
Responsibilities:
Monitor performance through appropriate Key Performance Indicators (KPIs) for CAPA, Change Control, and Risk Management. Ensure a timely completion of actions identified in: Exception Reporting System, Change Management or Risk Management quality records and programs.
Provide leadership to ensure that actions are properly reviewed in order to ensure appropriate definition and timely completion of actions and review of significant trends/issues to prevent regulatory liabilities and financial losses. Evaluate if actions were effective and verified after implementation. Confirm that actions do not adversely affect the finished product.
Maintain the required databases necessary for tracking and trending to ensure actions are implemented and documented.
Facilitate meetings to ensure timely identification and management of events, including but not limited to triage and CAPA review board. Drive dialogue and discussion to ensure non-conformances are appropriately documented in a timely manner and that - when required - investigations are timely, rigorous and drive to root cause to facilitate the identification and implementation of effective corrections, corrective and preventive actions.
Provide in a timely manner information and analysis required for the Annual Quality Reviews, among other meetings.
Review and perform statistical analysis of all exception documents by reasons (re-inspections, NCR, Deviations and associated formal investigations). Correlate information and summarize it with the corresponding corrective actions. Identify if there are trends indicating the need for changes manufacturing or control procedures.
Experience Requirements:
This position requires knowledge in: quality / compliance management, visual inspection AQL and operator certification processes, aseptic processing operations, as well as regulations and standards affecting Biologics and Parenteral applications.
Qualifications :
Bachelor’s degree in Natural Sciences, preferably Biology, Chemistry or related field.
Experience in a Quality or technical field in the Pharmaceutical or Biotechnological industry preferred.
Quality/compliance management skills as well as regulations and standards.
Position requires computer literacy to manage multiple computer programs and databases.
Knowledge of data processing system, analytical competence, good verbal and written communication skills in both languages, English and Spanish.
Prior experience in CAPA, Change Control, and/or Risk Management is preferred.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
