Quality Assurance Consultant

Kelly Services; Houston (TX); On-site; USD 186,252,000 - 229,233,000; Full time

Benefits offered by this job

Medical, dental, vision

Transit spending account

Holiday pay

Paid sick leave

Job summary

Kelly Services seeks a Senior GMP Quality Assurance Consultant to provide on-the-floor QA support for clinical and commercial gene therapy manufacturing in the Houston area. This 3-4 month engagement reports to the Director of GMP Quality Assurance and involves real-time quality oversight and rapid decision-making.

The role requires 8+ years in GMP QA in gene therapy, hands-on documentation review, and regulatory knowledge.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Biotechnology, Engineering, or related field.
• 8+ years of direct GMP QA experience in gene therapy.
• Experience supporting DS/DP disposition and batch record review.

Responsibilities

• Provide on-the-floor GMP QA oversight for gene therapy manufacturing operations.
• Review and approve batch records, deviations, investigations, CAPAs, change controls and GMP docs.
• Support DS and DP disposition activities and product disposition.
• Provide risk-based QA guidance on complex quality issues.
• Review data and method validation documentation for GMP compliance.
• Provide real-time QA guidance during manufacturing and assist with audit readiness.

Skills

GMP QA

QA on-floor

Regulatory knowledge

Documentation review

Risk assessments

Education

Bachelor's degree in Bioscience/Engineering

Tools

Electronic batch records

QMS software

CAPA system

Job description

Job Title : Quality Assurance Consultant

Location: Houston, TX metro area (100% onsite)

Contract Duration : 3-4 months

Rate : $65-80/hour. (Negotiable/commensurate w/ experience)

Position Summary

The Senior GMP Quality Assurance Consultant will provide hands-on QA support for clinical and commercial gene therapy manufacturing. Reporting to the Director of GMP Quality Assurance, this consultant will provide real-time quality oversight, review and approve GMP documentation, support product disposition, and resolve complex quality issues in partnership with Manufacturing, QC, Regulatory, and Technical Operations.

Key Responsibilities

• 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 elevate 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.

Required Qualifications

• 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.

Preferred Qualifications

• QA experience supporting both clinical and commercial CGT manufacturing.
• Viral vector and/or advanced gene therapy experience.
• Regulatory inspection and inspection-readiness experience.
• Experience with electronic QMS and electronic batch record systems.
• Previous consulting experience in a GMP gene therapy environment.

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 Affluent 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.