Sr. Quality Assurance Consultant

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.  () for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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