Associate Quality Analyst I

Kelly Services; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Telemedicine

Term life

Whole life

Accident insurance

Critical illness

Legal plan

Short-term disability

Retirement plan

Service bonus

Holiday pay

Transit spending account

Paid sick leave

Job summary

Kelly Science, Engineering, Technology & Telecom (SETT) is seeking an Associate Quality Analyst to support a leading biopharmaceutical client in Barceloneta, Puerto Rico. This role focuses on leading quality processes, CAPA, Change Control and Risk Management to ensure product quality and regulatory compliance.

The position requires knowledge of quality/compliance management, AQL visual inspection, and aseptic processing operations, with English and Spanish communication skills.

Qualifications

• Bachelor’s degree in Natural Sciences (Biology or Chemistry preferred).
• Experience in a Quality or technical field in Pharmaceutical or Biotechnological industry preferred.
• Knowledge of CAPA, Change Control, and Risk Management.
• Proficient with data processing systems and multiple databases.
• Strong verbal and written communication in English and Spanish.

Responsibilities

• Lead quality processes that manage nonconformance, CAPA, Change Control and Risk Management.
• Monitor KPIs for CAPA, Change Control, and Risk Management.
• Ensure timely actions and verify effectiveness of corrective actions.
• Maintain databases for tracking and trending actions.
• Facilitate meetings for CAPA review and RCA discussions.
• Provide data for Annual Quality Reviews and other meetings.
• Analyze exception documents and correlate with corrective actions and trends.

Skills

Quality management

AQL inspection

CAPA

Change Control

Risk Management

Data analysis

Bilingual English/Spanish

Education

Bachelor's in Natural Sciences

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 Associate Quality 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

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, preferrably 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.

Daily Work Schedule ExpectationsALL candidates must be available for any shift/weekend/holidays.

Associate Rotating shift – 4 days at 10hours

2 months rotation on each shift 1 st , 2 nd , 3 rd shift

Area worked based in manufacturing schedule of 24/7

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type.

• 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.

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.

Kelly Services is proud to be an Equal Employment Opportunity and affirmative action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.