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Senior Quality Associate, Sterility Assurance
2 months ago
Kelly Science & Clinical is seeking a Senior Quality Associate, Sterility Assurance near Fort Dodge, IA.
Direct Hire
The 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
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