
Description
Quality Validations Engineer- Somerset NJ
Summary of Essential Functions:
The Quality Applications Engineer is tasked with supporting, maintaining, and optimizing digital quality systems and applications across the organization. This role ensures that all quality-related software tools are effectively implemented and aligned with regulatory requirements and business needs. The engineer collaborates with cross-functional teams to drive continuous improvement and system integration. Specific Duties, Activities, and Responsibilities:
- Serve as the technical lead for quality system applications including QMS, LIMS, and document control platforms.
- Configure, maintain, and troubleshoot quality software tools to ensure optimal performance and compliance.
- Collaborate with IT and Quality teams to implement system upgrades, integrations, and enhancements.
- Develop and maintain user documentation, training materials, and SOPs related to quality applications.
- Support internal and external audits by providing system access, data retrieval, and documentation.
- Analyze system data to identify trends and opportunities for process improvement.
- Ensure systems meet GMP, GLP, and other applicable regulatory standards.
- Provide end-user support and training across departments.
- Participate in validation activities for new systems and upgrades.
- Manage change control processes related to quality applications.
- Comply with Health, Safety, and Environmental responsibilities for the position.
- Adhere to company standards for data integrity and regulatory compliance.
- Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
- 3+ years of experience in quality systems or applications support within a regulated industry (pharmaceutical, biotech, or medical device).
- Experience with system validation and compliance documentation (IQ/OQ/PQ).
- Strong understanding of GMP/GLP regulations and quality system requirements.
- Hands-on experience with QMS platforms (e.g., MasterControl), LIMS, and ERP systems.
- Familiarity with FDA 21 CFR Part 11 compliance and data integrity principles.
- Proficiency in SQL, data visualization tools, and reporting platforms.
- Excellent problem-solving, communication, and project management skills.
- Ability to translate business needs into technical solutions.
- Office-based role with occasional access to laboratory or manufacturing environments.
- Must adhere to all company safety protocols and procedures.
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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