Quality Assurance Supervisor
hace 20 días
Colorado Springs
Job Description Why Join New Generation Wellness As we approach our centennial milestone, New Generation Wellness is celebrating more than 100 years of commitment to health, quality, and innovation. Our longevity reflects a stable, science-driven organization where Quality plays a critical role in protecting consumers and enabling responsible growth. At NGW, Quality Assurance is empowered, respected, and embedded in decision-making. This role offers hands-on leadership, strong cross-functional partnership, and a clear path into senior Quality leadership. Position Summary: The Quality Assurance Supervisor provides daily leadership and oversight of Quality Assurance activities supporting manufacturing, packaging, and quarantine operations in a cGMP-regulated environment. This role ensures compliance with FDA regulations, internal SOPs, and quality-system requirements while fostering a proactive, collaborative quality culture. Reporting to the Quality Manager, the QA Supervisor leads and mentors QA staff, supports audit readiness, drives documentation accuracy, and partners closely with Operations and Product Development to ensure product quality and regulatory compliance. This is an ideal opportunity for a hands-on QA professional ready to expand their leadership impact while maintaining direct involvement in quality systems and floor-level execution. Key Responsibilities QA Leadership & Daily Oversight • Supervise day-to-day QA activities across manufacturing, packaging, and quarantine operations, • Lead, train, and mentor QA Technicians, providing coaching, performance feedback, and scheduling support, • Serve as a visible quality presence on the production floor, • Exercise authority—with organizational support—to stop production or withhold product release when quality or compliance risks are identified Quality Systems & Compliance • Support equipment qualifications (IQ/OQ) and cleaning validation activities, • Partner with Supplier Quality to support raw-material and vendor qualification processes, • Review batch records and oversee documentation accuracy and completeness, • Coordinate deviation investigations, nonconformance documentation, and CAPA activities, • Support root-cause analysis and track CAPA effectiveness, • Manage change-control documentation to ensure traceability and regulatory alignment, • Track and trend quality metrics and report findings to Quality leadership Training & Technical Support • Coordinate QA-related training programs in collaboration with HR and department leaders, • Ensure training records are current and aligned with role-specific competencies, • Act as a technical resource and mentor for QA Technicians Auditing & Inspection Readiness • Participate in internal and external audits, serving as a subject matter expert, • Support preparation for FDA and customer inspections, • Monitor and follow up on corrective actions resulting from audit findings Cross-Functional Collaboration & Continuous Improvement • Partner with Manufacturing, Product Development, and Supply Chain to support compliant, efficient operations, • Participate in quality review boards and continuous improvement initiatives, • Identify opportunities to improve documentation flow, approval timelines, and QA processes, • Support enhancements to electronic Quality Management Systems (QMS) Success Measures • Accuracy and timeliness of batch record and document reviews, • Deviation and CAPA closure effectiveness, • Audit readiness and inspection outcomes, • Training completion and team development progress, • Contributions to quality culture and process improvement initiatives Qualifications Education • Bachelor’s degree in a scientific or technical discipline (Biology, Chemistry, Food Science, or similar) preferred, • Equivalent regulated-industry experience will be considered Experience • 4–6 years of Quality Assurance experience in a regulated manufacturing environment (dietary supplements, nutraceuticals, pharmaceuticals, food, or similar FDA-regulated industry), • 1–2 years of experience in a lead or supervisory capacity preferred, • Hands-on experience with batch record review, deviation investigations, CAPA management, and internal audits Knowledge & Skills • Strong working knowledge of cGMPs, FDA regulations, and Good Documentation Practices (GDP), • Experience working with ERP systems and electronic QMS platforms, • Strong analytical, organizational, and technical writing skills, • Ability to lead, mentor, and influence others in a fast-paced manufacturing environment, • Detail-oriented, accountable, and comfortable making quality-driven decisions Work Environment & Physical Requirements • Primarily office-based with regular time spent in manufacturing areas, • Requires extended periods of computer work and walking the production floor, • Occasional lifting up to 20 lbs, • Use of PPE including lab coat, hairnet, safety glasses, and hearing protection as required Applicants must be legally authorized to work in the United States. This position is not eligible for employment visa sponsorship. \nCompany Description As we prepare to embark on our centennial journey, New Generation Wellness (NGW) is not just marking a milestone; we are celebrating a century of commitment to health, vitality, and positive transformation. For 100 years, we've been at the forefront of wellness, pioneering innovation, and shaping the future of holistic health. We invite you to be part of our legacy. Joining New Generation Wellness means becoming a part of a dynamic and successful team that values innovation, collaboration, and exceeding the needs of our customers. Here's to the next 100 years of New Generation Wellness! More importantly, here’s to your success! As we prepare to embark on our centennial journey, New Generation Wellness (NGW) is not just marking a milestone; we are celebrating a century of commitment to health, vitality, and positive transformation. For 100 years, we've been at the forefront of wellness, pioneering innovation, and shaping the future of holistic health. We invite you to be part of our legacy. Joining New Generation Wellness means becoming a part of a dynamic and successful team that values innovation, collaboration, and exceeding the needs of our customers. Here's to the next 100 years of New Generation Wellness! More importantly, here’s to your success!
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