Quality Specialist Job Listing at Kelly Services in Fajardo, Fajardo (Job ID US3620733_BH10019957)

Description

Job Summary:
The Quality Specialist ensures compliance throughout the investigation and reporting processes and manages GMP documentation review, approval, and archiving. This role supports quality metrics, data gathering, and various projects while strictly following Standard Operating Procedures (SOPs), maintaining required training, and upholding good documentation practices. The specialist reviews and approves batch records, non-conformances (NC), corrective and preventive actions (CAPAs), and change control records, and uses multiple GMP databases for data input, queries, and status management. The position requires a strong understanding of regulatory requirements, quality principles, and technical writing proficiency. Key Responsibilities:

• Ensure investigations and reports comply with applicable regulations and company standards.
• Review, approve, and archive GMP documentation, including batch records, NCs, CAPAs, and Change Control records.
• Support the collection of metrics, data analysis, and project-based activities as needed.
• Adhere to and follow detailed Standard Operating Procedures (SOPs).
• Maintain current training records and perform good documentation practices for all controlled documents.
• Utilize databases for data entry, queries, managing statuses, and archiving documentation.
• Demonstrate comprehensive knowledge of regulatory requirements and quality principles.
• Provide assistance in compiling reports and technical documents for audits, inspections, and customer inquiries.
• Interact with customers as part of complaints investigation process and provide timely feedback and support.
• Collaborate with other departments to resolve quality issues and support continuous improvement efforts.

Qualifications:

• Bachelor's degree in Sciences (Biology, Chemistry, or related field).
• 1–2 years of experience in complaints investigations, regulatory reporting, and customer interaction within a GMP-regulated environment.
• Experience with quality management systems, Microsoft Excel, and multiple GMP databases.
• Demonstrated technical writing skills and attention to detail.
• Strong understanding of GMP, regulatory requirements, and quality principles.
• Fully bilingual (Spanish and English), both written and verbal.
• Excellent organizational, time management, and problem-solving abilities.

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.

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