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Kelly Services Associate Quality Analyst in Barceloneta, Puerto Rico

Kelly® Science & Clinical is seeking Associate Quality Analyst for contract position at Pharmaceutical client in Puerto Rico North area.

Position Summary/Purpose:

Workers should be available to work on rotating shift every week due to 24/7 new business operation. final schedule still under revision. During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the plant including performing Line Inspections, Quality Visual Inspections and Tub Hold management process. The incumbent supports the visual inspection certification process, resolution of deviations, participating in investigations, and assurance of compliance with cGMP and Customer policies for the manufacturing plant.

Responsibilities:

• Responsible for performing the SVP Line Inspections, Quality Visual Inspection (i.e. AQL) and provide support for the Tub Hold Management process.

• Supports Visual Inspection Certification Process. May act as Subject Matter Expert (SME) for the Visual Inspection Process.

• Support quality goals ensuring that all practices and procedures comply with GPO and Corporate policies and applicable regulations for the Quality areas under his/her responsibility.

• Support SVP Media Fill Program and QA Oversight execution activities.

• Place product on QA hold when required. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.

• Revise standard operating procedures; ensures procedures comply with Customer policies and cGMP guidelines.

• Demonstrates accountability and responsibility of EHS performance and compliance Additional requirements that we are looking for are:

• Aseptic processing experience

• Quality Assurance experience

• Visual inspection of parenteral products experience

• Participation and/or experience in Aseptic Process Simulation (Media Fills)

• Prior experience/certification in sterile gowning

• Prior experience in surveillance of aseptic filling process is a plus

Requirements

Education: Bachelor degree in biotechnology/biopharma, biology, chemistry or engineering. Pharmaceutical experiences can be considered. Master degree is not needed. at least 1 year biotechnology/biopharma with aseptic processing experience is desired

• Aseptic processing experience

• Quality Assurance experience

• Visual inspection of parenteral products experience

Daily Work Schedule Expectations Rotating shift and weekend – All candidates must be available to work any shift including weekend, based in business needs .

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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 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.

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.

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