Quality Assurance Specialist

Kelly Services; Barceloneta (PR); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid holidays

Job summary

Kelly® Science, Engineering, Technology & Telecom (SETT) in Barceloneta, PR is seeking a Quality Assurance Specialist to join our global biopharmaceutical client team. The role focuses on maintaining high quality standards and ensuring regulatory compliance across the manufacturing network.

The ideal candidate holds a bachelor's degree in engineering or science with at least six years of pharma operations experience, including GMP knowledge, and is fluent in English and Spanish.

Qualifications

• Bachelor’s degree preferably in Engineering or Science with related pharma experience.
• Strong knowledge of GMP regulations and quality concepts.
• Experience with quality systems and regulatory compliance is preferred.

Responsibilities

• Responsible for product quality assurance across the functional area.
• Ensure conformance to Customer’s Quality System requirements and regulatory standards.
• Support troubleshooting and resolution of quality compliance issues.
• Communicate quality initiatives and projects to management.
• Ensure compliance with Customer’s Quality Systems and cGMPs.

Skills

Analytical skills

GMP knowledge

Quality systems

SAP & LRMS

Bilingual EN-ES

Independent worker

Education

Bachelor’s degree in Engineering or Science

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 Specialist 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

The Quality Associate supports the Global Biologics Quality Function within Operations. Expectations that the Quality Associate III will maintain high-quality levels on all aspects of their job, while achieving high levels of efficiency.

Responsibilities

• Responsible for various aspects of the product’s quality assurance related to their functional area.
• Ensures that product is consistently manufactured in conformance with Customer’s Quality System requirements and all applicable regulatory requirements throughout the network, including third party manufacturers.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with management for Quality Initiatives, Projects, Product Transfers, etc.
• Incumbent is responsible for ensuring compliance with Customer’s Quality Systems and cGMPs.

Qualifications

. Bachelor’s degree preferably in Engineering or Science & Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process

1. Strong analytical skills and attention to detail and, strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
2. Knowledge of GMP regulations and standards affecting pharmaceutical products
3. Comprehensive knowledge and application of business and quality concepts
4. Change plan, Exception Reports, SAP and LRMS experience is highly preferred
5. Fully Bilingual English & Spanish
6. Candidate may work independently and have experience in Quality systems.

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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Anti­Affirmative 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.