Sr. Quality Assurance Consultant

Kelly Services; Houston (TX); Presencial; USD 90.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Transit spending account

Paid holidays

Retirement savings plan

Medical insurance

Dental insurance

Vision insurance

Paid sick leave

Descripción de la vacante

Kelly Services is seeking a Sr. Quality Assurance Consultant in Houston, TX, to oversee GMP QA for gene therapy manufacturing. The role emphasizes on-the-floor oversight, batch record review, deviations and CAPAs, and collaboration with cross-functional teams.

The ideal candidate has a biology/chemistry/biotech/engineering background with 8+ years of GMP QA experience in gene therapy and regulatory knowledge to ensure inspection readiness.

Formación

• Bachelor's degree in a scientific/technical discipline.
• 8+ years of GMP QA experience in gene therapy.
• Direct QA support on manufacturing floor.

Responsabilidades

• Provide on-the-floor GMP QA oversight for gene therapy manufacturing operations.
• Review and approve batch records, deviations, CAPAs, change controls, and GMP docs.
• Support DS/DP disposition activities and regulatory readiness.

Conocimientos

GMP QA knowledge

QA on the floor

Regulatory compliance

Analytical reviewing

Risk assessment

Educación

Bachelor's degree in Biology, Chemistry, Biotechnology, or Engineering

Descripción del empleo

Feeling stuck? Put your career in motion with a great, new opportunity. Join the Kelly® Science & Clinical team as a Sr. Quality Assurance Consultant to work at a leading Biotechnology organization in Houston, TX. We’re here every step of the way to help you and your career be the best it can be. Bring your energy and expertise. We’ll help you get where you want to be.

Pay Rate: $65-80/hour(commensurate with experience)

Contract Duration: 3-4 months

Why you should apply to be a Sr. Quality Assurance Consultant:

• Opportunity to support cutting-edge gene therapy manufacturing.

• Work onsite with a collaborative, cross-functional team driving innovation in life sciences.

• Contribute directly to accelerated clinical development and IND-enabling studies.

• Gain exposure to a transformative environment as the company advances from pre-clinical to clinical stages.

What’s a typical day as Sr. Quality Assurance Consultant? You’ll be:

• Provide on-the-floor GMP Quality Assurance oversight for gene therapy manufacturing operations.

• Review and approve executed and master batch records, deviations, investigations, CAPAs, change controls, and other GMP manufacturing documentation.

• Support drug substance (DS) and drug product (DP) disposition activities.

• Evaluate complex quality and compliance issues associated with gene therapy manufacturing and provide risk-based QA guidance.

• Review manufacturing records, raw laboratory data, analytical results, and method validation documentation for GMP compliance.

• Provide real-time QA guidance during manufacturing and accelerate potential product-quality or compliance risks.

• Partner with Manufacturing, QC, Regulatory, and Technical Operations to resolve quality issues and maintain inspection readiness.

• Support regulatory inspections and ensure documentation is complete, scientifically justified, and audit-ready.

This job might be an outstanding fit if you:

• Have a Bachelor's degree in Biology, Chemistry, Biotechnology, Engineering, or related scientific/technical discipline.

• 8+ years of direct GMP Quality Assurance experience within the gene therapy industry.

• Demonstrated QA experience supporting gene therapy product manufacturing, preferably viral vector based products.

• Direct experience providing QA support on the manufacturing floor.

• Experience reviewing and approving executed batch records and complex GMP documentation.

• Experience supporting DS and DP product disposition.

• Experience reviewing raw data, laboratory records, analytical results, and method validation documentation.

• Strong knowledge of FDA regulations, ICH guidelines, cGMP requirements, deviations, CAPAs, change controls, investigations, and risk management.

• Ability to independently assess complex quality issues and make sound, risk-based QA decisions.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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 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 process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affine Actions 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.