We have other current jobs related to this field that you can find below

  • Quality Assurance Manager

    2 months ago

    Miami, United States Community Medical Group Full time

    Job DescriptionJob DescriptionSummaryThe Quality Assurance Manager is responsible for implementing the company’s Continuous Quality Improvement Program at the corporate level including, but not limited to, planning, organizing, developing, coordinating, and directing quality assessments. They will ensure activities and programs in facilities are accordance...

  • Quality Assurance Technician

    13 hours ago

    Miami Gardens, Florida, United States QUALITY AIRCRAFT PARTS Full time

    Position OverviewQuality Aircraft Parts is seeking a dedicated Quality Control Assistant to enhance our quality assurance team.This is a full-time role, directly reporting to the Quality Control Director.Applicants must possess A & P Licenses.Our facility is strategically located to provide easy access to major transportation hubs, ensuring we adhere to the...

  • Quality Assurance Manager

    2 weeks ago

    Miami, United States Connect Life Science Full time

    Quality Assurance Manager Miami Pharma $120,000 Job Summary:Our client is seeking a detail-oriented and experienced Quality Assurance (QA) Mid Manager to join the team in Miami, FL. The ideal candidate will have significant experience in Quality Management Systems (QMS), with a strong focus on working with computer systems, implementations, complaints...

  • Quality Assurance Manager

    2 weeks ago

    Miami, United States Connect Life Science Full time

    Quality Assurance Manager Miami Pharma $120,000 Job Summary:Our client is seeking a detail-oriented and experienced Quality Assurance (QA) Mid Manager to join the team in Miami, FL. The ideal candidate will have significant experience in Quality Management Systems (QMS), with a strong focus on working with computer systems, implementations, complaints...

  • Compliance and Quality Assurance Manager

    1 month ago

    Miami, Florida, United States teamworkonline Full time

    OverviewThis strategic and pivotal role is instrumental in achieving excellence in venue management and customer service. It oversees quality and compliance in all operational, managerial, and maintenance facets. Collaborating closely with leadership, various departments, contract partners and key external stakeholders, this position spearheads the...

  • Manager, Quality Assurance, Bakery

    3 months ago

    Miami, Florida, United States Restaurant Brands Full time

    About Restaurant Brands International:Restaurant Brands International Inc. is one of the world's largest quick service restaurant companies with over $40 billion in annual system-wide sales and over 30,000 restaurants in more than 100 countries. RBI owns four of the world's most prominent and iconic quick service restaurant brands – TIM HORTONS, BURGER...

  • Quality Assurance Associate

    6 days ago

    Miami, Florida, United States Smart Distribution Full time

    Job OverviewSmart Distribution is a prominent logistics provider dedicated to delivering superior products across diverse sectors. We are currently in search of a meticulous and committed Quality Control Assistant to enhance our quality assurance efforts.In the role of Quality Control Assistant, you will be instrumental in guaranteeing that our offerings...

  • Quality Assurance Supervisor

    17 hours ago

    Miami, Florida, United States Chenega Corporation Full time

    Overview CHENEGA CORPORATION The Quality Control Manager plays a pivotal role in overseeing the quality assurance framework and ensuring that subcontractors adhere to a robust quality management system that aligns with contractual obligations. This position entails the independent administration of the quality control program, empowering the manager...

  • Manager, Quality Assurance, Bakery

    3 months ago

    Miami, United States Restaurant Brands Full time

    About Restaurant Brands International: Restaurant Brands International Inc. is one of the world's largest quick service restaurant companies with over $40 billion in annual system-wide sales and over 30,000 restaurants in more than 100 countries. RBI owns four of the world's most prominent and iconic quick service restaurant brands – TIM HORTONS®,...

  • Salesforce Quality Assurance Manager

    6 days ago

    Miami, United States StevenDouglas Full time

    We are collaborating with a prominent real estate firm seeking to add a Salesforce Quality Assurance Manager to their expanding workforce.This position necessitates 3-4 days per week onsite. *Only local candidates will be considered*Key Responsibilities:Oversee the testing of Salesforce applications and their integrations.Create detailed test plans,...

  • Salesforce Quality Assurance Manager

    15 hours ago

    Miami, United States StevenDouglas Full time

    We are collaborating with a prominent real estate firm seeking to add a Salesforce Quality Assurance Manager to their expanding workforce.This position necessitates 3-4 days a week onsite in the Miami region. *Only local candidates will be considered*Key Responsibilities:Oversee the testing of Salesforce applications and their integrations.Craft detailed...

  • Quality Assurance Lead

    6 days ago

    Miami, Florida, United States Community Medical Group Full time

    Job OverviewPosition SummaryThe Quality Assurance Manager at Community Medical Group plays a pivotal role in executing the organization's Continuous Quality Improvement Program at a corporate level. This position encompasses planning, organizing, developing, coordinating, and directing quality evaluations. The manager ensures that all activities and programs...

  • Quality Assurance Supervisor

    19 hours ago

    Miami, Florida, United States Chenega Corporation Full time

    Overview CHENEGA CORPORATION The Quality Control Manager plays a crucial role in overseeing the quality assurance program and ensuring that subcontractors adhere to a robust quality management framework that aligns with contractual obligations. This position holds the authority to manage the quality control processes independently, ensuring that all...

  • Quality Assurance and Regulatory Affairs Manager

    6 days ago

    Miami, Florida, United States Lumen Resources Full time

    Position Overview: We are in search of a proficient and knowledgeable Quality Assurance / Regulatory Manager who possesses a robust foundation in product innovation, safety protocols, and risk assessment.Key Responsibilities:Conducting audits for co-packers and suppliers, along with comprehensive evaluations.Developing and implementing quality assurance...

  • Quality Assurance and Regulatory Affairs Manager

    5 days ago

    Miami, Florida, United States Lumen Resources Full time

    Position Overview: We are looking for a dedicated and knowledgeable Quality Assurance / Regulatory Manager who possesses a robust background in product innovation, safety protocols, and risk assessment.Key Responsibilities:Conducting audits for co-packers and suppliers, ensuring thorough evaluationsDeveloping and implementing quality assurance standards and...

  • Quality Assurance Supervisor

    18 hours ago

    Miami, Florida, United States Continental Services Group Full time

    Job OverviewSalary Range: $55,000 - $80,000Role Summary:We are in search of a skilled Quality Assurance Supervisor dedicated to upholding the highest standards of quality and regulatory adherence in our biological products for In-Vitro diagnostics and research. This position presents a unique opportunity to spearhead quality assurance strategies, foster...

  • Quality Assurance Associate

    17 hours ago

    Miami, Florida, United States Smart Distribution Full time

    Job OverviewSmart Distribution is a prominent logistics firm dedicated to providing top-notch products to a diverse range of sectors. We are currently in search of a meticulous and committed Quality Control Assistant to enhance our operations.In the role of Quality Control Assistant, you will be instrumental in guaranteeing that our products adhere to the...

  • Quality Assurance Specialist

    18 hours ago

    Miami, United States The Heico Companies Full time

    Job SummaryThe Heico Companies is seeking a highly skilled Quality Assurance Specialist to ensure that our construction projects meet the highest standards of quality, safety, and compliance.Key ResponsibilitiesCommunicate Quality Standards: Ensure that all stakeholders, including business partners, field staff, and project managers, understand and adhere to...

  • Quality Assurance Technician

    16 hours ago

    Miami Gardens, Florida, United States QUALITY AIRCRAFT PARTS Full time

    Job OverviewQuality Aircraft Parts is seeking a dedicated Quality Control Assistant to join our team. This is a full-time role that reports directly to the Director of Quality Control.Key Responsibilities:Conducting thorough incoming inspectionsPerforming in-process quality assessmentsExecuting manual maintenance tasksCarrying out testing...

  • Senior Internal Audit Quality Assurance Manager

    1 day ago

    Miami, United States Visa Full time

    Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year. Our mission is to connect the world through the most innovative, convenient, reliable, and secure...

Manager, Quality Assurance

2 months ago

Miami, United States The University of Miami Full time
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 or staff position using the Career worklet, please review this tip sheet.

The Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine is actively seeking a dedicated Quality Assurance Manager to oversee the quality control and assurance of all clinical trials within the Clinical Trials Division and cGMP operations. Reporting to the Executive Director of the Clinical Research Cellular Therapy Manufacturing Program (CRCMP), this full-time position is critical in supporting the Medical School's vision, mission, goals, and objectives by ensuring that clinical trials are conducted in compliance with relevant regulatory standards and that the quality management system of the CRCMP complies with all cGMP requirements for cell manufacturing for clinical applications.

JOB FUNCTIONS
  • Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements, and conducts inquiries of laboratories and research protocols.
  • Prepares reports of investigations and inquiries for internal or external use.
  • Assists in the preparation and presentation of educational programs.
  • Conducts the preparation of research teams for FDA or other regulatory agency audits.
  • Assists research teams with required written responses to observations resulting from audits conducted by regulatory agencies.
  • Reviews audit reports and plans of quality assurance auditors.
  • Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research and recommends changes to administrative policies and procedures.
  • Creates, revises, and maintains internal policies and standard operating procedures, as well as University-wide policies intended to assist University researchers in maintaining compliance with research standards and guidelines.
  • Assists with the preparation of annual reports, summarizing efforts taken and changes to be implemented at both University and department levels.
  • Maintains quality assurance related databases and electronic and paper audit files.
  • Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
Education:

Bachelor's degree; Master's degree is preferred

Certification and Licensing:

Clinical Research, Research Compliance, or Auditing GCP related fields is preferred

Experience:

5 years of relevant experience; preparing submissions and dealing with the FDA and other regulatory agencies, is preferred

Knowledge, Skills, and Abilities:
  • Ability to maintain effective interpersonal relationships
  • Ability to communicate effectively in both oral and written form
  • Skill in collecting, organizing and analyzing data
  • Ability to recognize, analyze, and solve a variety of problems
  • Ability to exercise sound judgment in making critical decisions
Department Specific Functions
  • Responsible for establishing and implementing robust quality control systems, managing the efficient review of submitted research and ensuring consistency with regulatory requirements
  • Includes accurate and timely processing, tracking, and filing of submissions to regulatory agencies such as FDA, FACT, and AABB.
  • Maintaining meticulous records of IRB actions, documenting communications with investigators, regulatory entities, and other stakeholders involved in the conduct of research.
  • Responsible for maintaining facility accreditations and managing the renewal process
  • Responsible for working on the CMC sections of the IND, ensuring comprehensive documentation and compliance with all regulatory guidelines
  • Oversees quality assurance, assessment, and compliance of clinical trials, ensuring all activities adhere to GCP, ICH, and FDA regulations
  • Determines that Standard Operation Procedures (SOPs), are accurately defined and followed; which should be reviewed annually to ensure accuracy and appropriateness to actual practices
  • Responsible for ensuring compliance with all applicable federal, state, local regulations that dictate Good Documentation Practices
  • Conducts comprehensive internal audits of the entire quality system and provides proper corrective/preventative recommendations
  • Responsible for CAPA review and implementation
  • Manages Adverse Event reporting and documents corrective action as appropriate
  • Prepares for and supports external monitoring and audits of clinical trials, ensuring trial consistency with IRB approved proposals and adherence to relevant laws and regulations
  • Summarizes and reports any findings or deviations to senior management
  • Leads the development and implementation of regulatory compliance strategies within the ISCI's cGMP operations, including the monitoring and auditing of clinical manufacturing processes
  • Generates, submits, and manages Investigational New Drug (IND) submissions and Serious Adverse Effects (SAE) reports, responding to regulatory agency inquiries and maintaining correspondence files
  • Interfaces with regulatory agencies, serving as a liaison to ensure that all manufacturing activities are compliant with current regulations
  • Organizes and directs training programs for ISCI employees on regulatory requirements governing clinical and manufacturing practices, including HIPAA compliance
  • Designs and oversees monitoring programs that ensure the safety of human and animal subjects involved in clinical trials and manufacturing processes
  • Regularly review and adapt processes to incorporate new quality and regulatory changes in industry trends
  • Develops and manages systems to support auditing activities, including organizing panels of experts for reviews and risk analysis
  • Performs other related duties as required, ensuring all responsibilities are executed in accordance with the institution's standards and objectives


The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:
Full time

Employee Type:
Staff

Pay Grade:
H13