Sr Quality Engineer
2 weeks ago
Senior Quality Engineer Join to apply for the Sr Quality Engineer role at Katalyst CRO Responsibilities Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements. Ensure all processes and products comply with applicable regulatory standards, including cGMP. Lead continuous improvement initiatives to enhance product quality, efficiency, and compliance. Oversee validation activities, including equipment, process, and cleaning validations, ensuring compliance with industry standards. Conduct thorough investigations into quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Plan and conduct internal audits, support external regulatory inspections, and manage responses to audit findings. Evaluate and qualify suppliers, conduct supplier audits, and ensure supplier compliance with quality standards. Maintain accurate and comprehensive quality documentation, including SOPs, batch records, and validation protocols. Mentor and develop junior quality engineers and quality assurance staff, fostering a culture of continuous improvement and quality excellence. Perform risk assessments and implement risk mitigation strategies related to product quality and regulatory compliance. Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into all phases of product development and production. Requirements 7-10 years of experience in Quality Assurance within a FDA/GMP environment (pharmaceutical or medical device industry required). Bachelor's degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required. Proficiency in quality management software, statistical analysis tools, and methodologies such as Six Sigma, Lean. Strong understanding of Quality Management Systems. Previous experience with hosting client audits and/or regulatory inspections. Excellent communication skills. Additional Skills & Qualifications Certified Quality Engineer (CQE) or Certified Quality Auditor certification preferred. Experience with electronic Quality and Training Management Systems. Seniority Level Mid-Senior level Employment Type Contract Job Function Quality Assurance Industries Pharmaceutical Manufacturing Location St Charles, MO Referrals increase your chances of interviewing at Katalyst CRO by 2x #J-18808-Ljbffr
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Sr Dir Quality
7 days ago
St. Louis, United States Paladin Full timeSr. Director, QualityWe want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our...
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***Sr. Quality Engineer***
2 weeks ago
St Louis, United States Missouri Staffing Full timeSenior Quality Engineer We are seeking a highly experienced and motivated Senior Quality Engineer to join our pharmaceutical manufacturing team. The ideal candidate will have a strong background in quality assurance within the pharmaceutical industry, with a comprehensive understanding of regulatory requirements, quality systems, and process improvements....
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Sr. QA Test Automation Engineers
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St Louis, United States Kyyba Full timeSr. QA Test Automation Engineer Are you a Sr. QA Test Automation Engineer seeking a dynamic and rewarding opportunity? Our client, a public sector client, is looking for a talented Sr. QA Test Automation Engineer to join their growing team in St Louis, MO. About Kyyba: Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence...
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Sr Dir Quality
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St Louis, Missouri, United States ENDO INTERNATIONAL PLC Full timeWhy Us?We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values...
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Sr Dir Quality
1 week ago
St Louis, Missouri, United States Paladin Pharma Full timeWhy Us?We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values...
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Requisition ??Sr. QA Engineer?
4 weeks ago
St Petersburg, United States General Dynamics Full timeSr. Program Quality Engineer General Dynamics Ordnance and Tactical Systems (GD-OTS), a premier provider of ordnance weapons and tactical systems to the U.S. Department of Defense and allied nations, has an opening for an onsite Sr. Program Quality Engineer to join our St. Petersburg, FL team. We take pride in supporting the mission of the warfighter by...
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Sr. Project Manager, Engineering
7 days ago
St Louis, United States American Water Full timeJoin to apply for the Sr. Project Manager, Engineering role at American Water. Sr. Project Manager, Engineering responsible for managing the complete lifecycle of medium to large capital investment projects in water and wastewater systems, ensuring delivery on scope, schedule, and budget while maintaining regulatory compliance and company standards. Key...
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Sr. Project Engineer
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St Louis, MO, United States Barton Malow Full timeCompany: Barton Malow BuildersJob Location: St. Louis, MOPosition: Sr. Project EngineerREQ ID: 11595POSITION SUMMARY Barton Malow Builders is seeking a Sr. Project Engineer to join our team on a project in St. Louis, MO. This role involves overseeing project quality, compliance, budgets, and schedules. This role requires a 4-year degree in engineering or...
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DevOps Engineer, Sr.
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St Louis, MO, United States William C Brown Inc Full timeDevOps Engineer, Sr. EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Description Deliver simple solutions to complex problems...
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DevOps Engineer, Sr.
7 days ago
St Louis, MO, United States William C Brown Inc Full timeDevOps Engineer, Sr. EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Description Deliver simple solutions to complex problems...
