Miami, Florida, United States · On-site
Description The Sr. Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc. Serves as a mentor to the Quality Engineer Specialists and …
Skills: Quality Assurance, CAPA Management, Root Cause Analysis, FDA Compliance, AATB Guidelines
Miami, Florida, United States · Remote OK
$120k–$130k/yr
ABOUT THE ROLE: We are seeking a Pharmacist, Formulary & Clinical Strategy to join Rightway's growing Clinical Strategy team. This is an early-career role designed for a clinical pharmacist who is ready to apply their ma…
Skills: Formulary Management, Prior Authorization, Managed Care Pharmacy, AI Tool Proficiency, Data Interpretation
Miami, Florida, United States · On-site
A proprietary trading firm based in Miami is seeking a highly motivated Quantitative Trading Intern to join the team as an intern. In this role, you will apply analytical thinking and market intuition to pricing, executi…
Skills: Quantitative Trading, Algorithmic Trading, Market Making, Risk Management, Probability
Miami, Florida, United States · On-site
Job Summary The Neurology APRN works collaboratively with the Neurologist and other colleagues to provide comprehensive care to pediatric patients with neurologic concerns. The position requires a high degree of critical…
Skills: Pediatric Neurology, Clinical Expertise, Patient Assessment, Diagnostic Interpretation, Medication Prescription
Miami, Florida, United States · On-site
$18/hr–$22/hr
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Animal Husbandry, Non-Human Primate Handling, Biological Sample Collection, Medication Administration, Autoclave Operation
Miami, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Mass Spectrometry, Data Analysis, LC-MS, MSI, Sample Preparation
Miami, Florida, United States · Remote OK
$97k–$193k/yr
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who ta…
Skills: Site Management, Clinical Monitoring, Regulatory Compliance, Informed Consent, SIV Conduct
Miami, Florida, United States · Remote OK
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Regulatory Documentation, Clinical Trial Management, FDA Compliance, NIH Regulations, IRB Submission
Miami, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Scientific Research, Data Analysis, Manuscript Preparation, Single-cell Multi-omic Research, Genomic Research
Miami, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Patient Assessment, Nursing Care Documentation, Medication Administration, Patient Education, Discharge Planning
Miami, Florida, United States · On-site
$58k–$76k/yr
Baptist Health is the region's largest not-for-profit healthcare organization, with 12 hospitals, over 29,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across …
Skills: Data Collection, Data Analysis, Data Interpretation, Statistical Skills, Mathematical Skills
Miami, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Basic Research, Applied Research, Scientific Writing, Experimental Design, Data Analysis
Miami, Florida, United States · Hybrid
$155k–$180k/yr
Overview The KAM position is focused on establishing access and demand for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision ma…
Skills: Account Management, Clinical Data Communication, Formulary Access, Territory Planning, Relationship Building
Miami, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Clinical Research Coordination, Participant Recruitment, Data Collection, Specimen Processing, Regulatory Compliance
Miami, Florida, United States · Hybrid
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Patient Education, Care Coordination, Triage, Holistic Evaluation, Interpersonal Relationships
Miami, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Data Management, Clinical Research Protocols, Chart Review, Patient Pre-screening, Data Collection
Miami, Florida, United States · On-site
Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before s…
Skills: Preventive Medicine, Clinical Care, Dermatological Assessment, Cardiovascular Assessment, Patient Education
Miami, Florida, United States · Remote OK
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Regulatory Documentation, Clinical Trial Management, FDA Compliance, NIH Regulations, IRB Submission
Miami, Florida, United States · Hybrid
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Grant Administration, Budget Development, Pre-award Support, Post-award Support, Regulatory Compliance
Miami, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Pharmacy, Patient Care, Pharmaceutical Knowledge
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The Sr. Quality Assurance Engineer maintains quality metrics and manages the CAPA system to ensure product safety and regulatory compliance. They lead root cause investigations, mentor junior engineers, and collaborate cross-functionally to implement process improvements.
Requires a Bachelor's degree in engineering or a related technical field with 5-6 years of experience in Quality or Engineering roles. Experience in Tissue Banking, Pharmaceuticals, or Biologics and knowledge of FDA/AATB guidelines are preferred.
Description
The Sr. Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc. Serves as a mentor to the Quality Engineer Specialists and Quality Engineers I/II. The role assists in the planning, development, implementation, communication, and maintenance of Vivex’s quality management systems, polices, documentation, data, and customer requirements. The Sr. Quality Assurance Engineer is expected to work with all departments to ensure compliance, that the final products are safe, reliable, and effective, and the successful and timely completion of projects. The Quality Assurance Engineer is mainly responsible for the maintenance of CAPA system items. They play a key role in preventing issues or fixing them if they arise by defining, monitoring, and approving the processes needed to achieve production standards.
Requirements
Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards.
While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
No direct reports (Individual contributor role)
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.
Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
Vivex develops and delivers innovative allografts designed to support the body’s healing potential to help improve patient outcomes and quality of life. Our medical technologies date back 50 years to the founding of The University of Miami Tissue Bank in 1970. Since that time, we have experienced multiple firsts in clinical and scientific achievements. Vivex’s strategic plan is focused on the development of new innovative allografts, research and development, enhancement of manufacturing capabilities, and sales and marketing efforts.
Offices: 2430 NW 116th St, Miami, Florida 33167, US · 3200 Windy Hill Road, Suite 1650W, Atlanta, Georgia 30339, US
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