Quality Assurance Specialist

Kelly Services; United States; Hybrid; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision

Telemedicine

Retirement plan

Paid holidays

Job summary

Kelly Science & Clinical is seeking a Quality Assurance Specialist to support Global Biologics Quality within Operations for a top biopharma client in the Barceloneta, PR area. The role focuses on maintaining high-quality standards and regulatory compliance across the network, including third-party manufacturers.

The ideal candidate has a science/engineering degree and 3+ years in pharma QA/R&D, with strong communication and LIMS/cGMP familiarity. Hybrid onsite schedule Tue, Wed, Thu on site.

Qualifications

• 3+ years of experience in Manufacturing, QA, or R&D in pharma/biologics/chemical industry.
• Familiar with statistical quality systems, electronic document management and LIMS.
• Familiar with Customer Quality Systems and regulatory requirements including cGMP.

Responsibilities

• Ensure product quality assurance across the specified functional area.
• Maintain conformance with Customer Quality System requirements and regulatory requirements across the network, including CMOs.
• Assist with troubleshooting and resolving quality compliance issues.
• Communicate quality initiatives and projects with management.
• Ensure compliance with Customer Quality Systems and cGMPs.

Skills

Statistical quality systems

Electronic document management

Laboratory information management

cGMP compliance

Strong communication

Education

Bachelor’s degree in Science or Engineering

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 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 required in Science or Engineering
• 3+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• Must also be familiar with Customer Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication Skills, both oral and written.

Hybrid Onsite Schedule Tues, Wed, Thurs on site

Benefits

• 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.

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