Kelly® Science & Clinical is seeking a Sr. Quality Engineer for a direct hire position at a cutting-edge Therapeutics Company client in the Los Angeles Area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.Salary: $119-130K DOEOverview This client is a cutting-edge therapeutics company working toward developing the next generation of cell therapies. In this role as Sr. Quality Engineer, you’ll be providing quality oversight for qualification and validation activities in both manufacturing and quality.Schedule: M-F 8AM -5PM OT and weekends may be required as necessary. 100% on-siteResponsibilities:
Lead validation efforts in support of new equipment and systems to keep pace with site capacity and life cycle.
Provide oversight of commissioning, qualification, and validation activities
Provide document review and approval of CQV and system life cycle documentation and ensure compliance with procedures.
Quality oversight on validation/qualification and/or facility/utility/equipment/computer system related deviations, CAPAs, and change controls.
Participate in cross functional teams for commissioning of new and existing manufacturing, warehouse and QC testing facilities and equipment.
Participate in Quality Department driven activities including Operational Excellence initiatives, Internal and External Audits, and Quarterly Management Reviews, as appropriate.
Qualifications:
Associate Degree with seven (7) years of experience, Bachelor of Science with five (5) years of experience, or Advanced Degree with three (3) year of experience or equivalent amount of education and experience.
Knowledge of industry standards and FDA / EMA /ICH regulations and guidelines including GMP management systems preferably in a cell and gene therapy drug development company
Experience in Facility Design and Improvement and associated validation requirements
Ability to work in controlled & classified cleanroom environment requiring donning of cleanroom garments (e.g., gowns, gloves, booties, hoods/masks, etc.)
Must be able to prioritize and develop detailed plans and execute multiple tasks and projects simultaneously.
Strong analytical, problem solving and critical thinking skills.
Excellent organizational and time management skills with a high level of attention to detail
Experience with Manufacturing and QC Analytical/Micro equipment and software (e.g., ddPCR, cell counters etc.)
What happens next:Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in the Kelly Science & Clinical network. That means our team of expert science & clinical recruiters will have access to your profile, making your opportunities limitless.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 (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 KellyWork 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 Services is proud to be an Equal Employment Opportunity and Affirmative 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.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative 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.