Kelly Science & Clinical is seeking a Senior Quality Associate, Sterility Assurance near Fort Dodge, IA.Direct HireThe Sterility Assurance Consultant will provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables of the manufacturing operations in the Biotech network to guarantee that the production and analytical processes are carried out with appropriate Sterility Assurance standards in alignment with Global procedures, GMP (Good Manufacturing Practices) and Regulatory expectations, as well as industry best practices. You will work cross-functionally to improve the site Sterility Assurance related processes and programs (aseptic training/qualification, APS (Aseptic Process Simulation) program, EM (Environmental Monitoring) program, etc.).Your Responsibilities:
Serve as the primary technical expert in contamination control, aseptic processing, and sterilization, providing guidance and support to manufacturing operations and ensuring adherence to regulatory requirements and industry best practices.
Lead and oversee the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance, including aseptic processing, media fills, and sterilization cycles.
Identify and troubleshoot issues related to sterility assurance, conduct root cause analyses, implement corrective actions, and drive continuous improvement initiatives to minimize process risks and optimize productivity.
Develop and deliver comprehensive training programs for operators, technicians, and other relevant personnel on sterility assurance principles, best practices, and regulatory requirements.
Ensure compliance with all applicable regulations and industry standards, prepare for and support regulatory inspections, and act as a subject matter expert during audits.
What You Need to Succeed (Minimum Qualifications):
B.S.in related field (Microbiology, Biology, etc.) or equivalent experience in lieu of degree 3+ years’ experience with sterile manufacturing Familiarity with Global Regulatory Standards FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), CFIA (Canadian Food Inspection Agency), as applicable.
Experience with a variety of technologies and platforms is preferred including poultry vaccine technologies, recombinant protein platforms, protein-based therapeutics, cell culture and fermentation technology.
What Will Give You a Competitive Edge (Preferred Qualifications):
Experience with upstream production of viruses in either cell monolayers, bioreactors and fermenters or experience with biologicals manufacturing and aseptic manufacturing Lean manufacturing and six sigma experience Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment are essential.
Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.
Interested? Apply now! #EX2BIO24As 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 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 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.
