
Description
QA Specialist (II or III)-Houston, TX
Kelly Science & Clinical is seeking a qualified QA Specialist to join the growing team of one of our leading biotechnology clients.
As a QA Specialist you will play a vital role in maintaining and improving their Quality Management System. This position supports compliance across operations, including manufacturing, documentation, auditing, and regulatory activities. You'll work cross-functionally with other departments to drive a culture of quality, safety, and continuous improvement.
Key Responsibilities
• Track and trend key quality indicators (KQIs) to ensure adherence to cGMPs and internal policies.
• Support internal and external audits, maintain audit schedules, and coordinate follow-up actions.
• Manage the document control system, archival room, and GMP documentation workflows.
• Administer the Learning Management System (LMS), assign and track training, and align curricula with department needs.
• Identify compliance risks and work with stakeholders to mitigate them.
• Lead or support initiatives to improve QA processes and enhance product quality.
• Monitor and manage timely closure and trending of these quality systems.
• Assist with regulatory submissions and communication with agencies.
• Develop and lead the tracking of QA metrics and present updates to leadership.
• Promote a right-first-time mindset and continuous improvement across the organization.
• Additional duties as assigned.
Qualifications
• Bachelor's degree in a relevant scientific field.
• Minimum 2+ years of QA experience in biotech, biopharma, or CDMO industries.
• Proven knowledge of FDA/EMA regulations, auditing practices, and QMS.
• Experience managing GMP documents, deviations, CAPAs, and change controls.
• Strong communication, analytical, and documentation skills.
• Proficiency with quality management software/tools.
This is a temp position with the possibility to become permanent. The work schedule is Monday-Friday, 8am-5pm. If you meet the above qualifications, please submit your resume for immediate consideration. #P1
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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