Tissue Quality Assurance Specialist
2 months ago
Position Summary
The Tissue Quality Assurance Specialist is tasked with overseeing and executing quality assurance assessments for human tissue donors, recovered tissues, and finalized processed grafts. This role necessitates direct communication with external laboratories to gather necessary documentation and collaboration with internal Operations and Quality Assurance teams to ensure that suitable samples are prepared for testing and that results are effectively communicated.
Key Responsibilities
Quality Assurance Testing and Reporting
- Conduct Quality Control (QC) assessments on tissue samples, which include but are not limited to, residual moisture, sterility, endotoxin levels, bioburden, cell characterization, flow cytometry, microorganism identification, and gram staining.
- Execute QC release assessments for microbiological media, materials, and reagents.
- Facilitate environmental monitoring (EM) within the facility by conducting routine assessments and processing samples.
- Inspect incoming materials and reagents, microbiological media, as well as in-process and final products.
- Review and manage test outcomes reported by external parties to ensure appropriate handling of tissues and grafts.
- Maintain comprehensive documentation of in-house tests and results reported by external laboratories.
- Prepare blood specimens, tissue samples, and media samples for dispatch to external testing facilities.
- Assist the Manager in maintaining laboratory inventory of media and reagents, as well as ordering necessary laboratory supplies.
- Support and implement qualification/validation protocols for QC testing methodologies.
General Duties
- Stay informed about relevant federal and state regulatory requirements and standards set by accrediting bodies.
- Report all discrepancies, errors, and deviations to Quality Assurance management. Engage in the investigation of complaints and deviations, including the development and execution of corrective actions.
- Participate in audits and inspections as required.
- Assist in accreditation and licensing processes.
- Perform additional responsibilities as assigned by the QC Manager and/or Director of Quality Assurance.
Qualifications
Education and Experience: A Bachelor’s degree in a scientific discipline is preferred, or an Associate degree in Science with two years of relevant experience. A combination of education and experience in a regulated environment (e.g., Biologics, Pharmaceutical) will also be considered.
Laboratory Skills: Proficiency in aseptic techniques, bioburden testing, sterility testing, endotoxin testing, growth promotion, flow cytometry, and gram staining.
Other Skills: Strong interpersonal, verbal, and written communication skills are essential. Must exhibit excellent organizational abilities and meticulous record-keeping skills. Attention to detail and the capacity to manage multiple tasks in a high-pressure environment are crucial. Must acquire knowledge of all regulations, laws, and standards governing the tissue banking industry within the first year of employment.
Technical Proficiency: Familiarity with Microsoft Office is required. Knowledge of Vitek 2, Spectrophotometer, Cell Analyzers, Autosampler, and MAGPIX is preferred.
Work Environment: The position primarily involves a fast-paced, laboratory-oriented work setting. Availability for evening and weekend work may be necessary.
Physical Requirements: The role requires the employee to sit or stand for extended periods. Occasionally, the employee may need to lift, pull, or move items weighing up to 20 pounds.
Direct Reports: This position does not have any direct reports.
-
Quality Assurance Specialist
2 weeks ago
Miami, Florida, United States VIVEX BIOLOGICS INC Full timeJob Title: Quality Compliance CoordinatorAt Vivex Biologics, Inc., we are seeking a highly skilled Quality Compliance Coordinator to join our team. This critical role will be responsible for managing and monitoring Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Supplier Corrective and Preventive Actions (SCAR), Complaints, Planned...
-
Quality Assurance Specialist
1 week ago
Miami, Florida, United States Actalent Full timeQuality Assurance SpecialistActalent is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of medical device products. This includes participating in quality assurance activities, working with doctors and engineers to develop high-quality devices, and defining quality...
-
Quality Assurance Specialist
4 days ago
Miami, Florida, United States VIVEX BIOLOGICS INC Full timeJob SummaryVIVEX BIOLOGICS INC is seeking a highly skilled Quality Control Analyst to join our team. As a Quality Control Analyst, you will be responsible for performing and managing results of quality control testing for human tissue donors, recovered tissues, and final processed grafts.Key Responsibilities:Perform Quality Control (QC) testing of tissue...
-
Miami, Florida, United States destinationone Consulting Full timeJob Title: Histotechnologist - Tissue Sample Preparation SpecialistAt destinationone Consulting, we're seeking a skilled Histotechnologist to join our team. As a Histotechnologist - Tissue Sample Preparation Specialist, you will play a crucial role in preparing tissue samples for microscopic examination, aiding in the diagnosis of diseases. Your expertise in...
-
Quality Assurance Specialist
1 week ago
Miami, Florida, United States Trigo ADR Americas Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Trigo ADR Americas. As a Quality Assurance Specialist, you will be responsible for performing inspection operations of in-process or completed hardware, including dimensional and visual inspection. You will also verify FAI's to AS9102 for accuracy and completeness.Key...
-
Hotel Quality Assurance Specialist
4 weeks ago
Miami, Florida, United States Ecolab Full timeJob Title: Hotel Quality Assurance SpecialistEcolab is seeking a highly skilled Hotel Quality Assurance Specialist to join its EcoSure division, an industry leader in brand protection programs. As a Hotel Quality Assurance Specialist, you will play a critical role in driving operational excellence and helping our clients grow their business.Key...
-
Quality Assurance Specialist
1 week ago
Miami, Florida, United States Pacific Seafood Full timeJob SummaryPacific Seafood is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products.Key Responsibilities:Develop and implement quality systems and procedures to ensure compliance with regulatory requirements.Conduct...
-
Quality Assurance Engineer I
2 weeks ago
Miami, Florida, United States VIVEX BIOLOGICS INC Full timeJob Title: Quality Assurance Engineer IJob Summary:Vivex Biologics, Inc. is seeking a highly skilled Quality Assurance Engineer I to join our team. The successful candidate will be responsible for developing, applying, revising, and maintaining quality metrics to support areas of operations at Vivex Biologics, Inc.Key Responsibilities:Lead specific tasks or...
-
Quality Assurance Specialist
2 weeks ago
Miami, Florida, United States Southeastern Printing Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Southeastern Printing. As a key member of our quality team, you will be responsible for developing and executing software test plans to identify software issues and ensure the highest quality products.Key Responsibilities:Monitor plant adherence to company quality...
-
Quality Assurance Specialist
1 week ago
Miami Gardens, Florida, United States MG STAFFING GROUP Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at MG STAFFING GROUP. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with policies and regulatory guidelines, providing expertise and guidance to operating entities, and leading audit and inspection preparation and resolution.Key...
-
Quality Assurance Engineer I
2 weeks ago
Miami, Florida, United States VIVEX BIOLOGICS INC Full timeJob Title: Quality Assurance Engineer IAt Vivex Biologics Inc., we are seeking a highly skilled Quality Assurance Engineer I to join our team. This role is responsible for developing, applying, revising, and maintaining quality metrics to support areas of operations.Key Responsibilities:Develop and implement quality metrics to ensure compliance with...
-
Tissue Processing Specialist
2 months ago
Miami, Florida, United States Lighthouse Lab Services Full timePosition Overview: Histology TechnologistA distinguished independent laboratory is in search of skilled Histology Technologists to enhance their team.Work Shifts:Early Morning: 5AM – 1:30PMNight Shift: 10PM – 6:30AMKey Responsibilities:Prepare specimens from human tissues and bodily fluids for microscopic analysis.Generate histopathological slides from...
-
Quality Assurance Specialist
2 weeks ago
Miami, Florida, United States Entegee Full timeJob OverviewEntegee is seeking a Quality Assurance Specialist to lead investigations and corrective actions for customer-related non-conformances in a manufacturing environment.Key Responsibilities:Lead teams to investigate the root cause of customer escapes and non-conformances.Determine and implement appropriate corrective/preventive actions.Review and...
-
Miami, Florida, United States Amazon Services Inc Full timeWe are seeking a highly skilled Pharmacist to join our team at Amazon Services Inc. as a Medication Quality Assurance Specialist. This role is a key part of our mission to provide customers with safe and convenient access to medications.The successful candidate will be responsible for verifying the quality of medications dispensed to customers, collaborating...
-
Staff Nurse
2 weeks ago
Miami, Florida, United States University of Miami Full timeJob Title: Registered Nurse Quality AssuranceUniversity of Miami is seeking a highly skilled Registered Nurse to join our team as a Quality Assurance Specialist.About the Role:This is a full-time position that requires a strong background in nursing and quality assurance. The successful candidate will be responsible for ensuring the highest standards of...
-
Quality Assurance Specialist
1 week ago
Miami Gardens, Florida, United States QRC Group, LLC Full timeAs a Quality Assurance Specialist at QRC Group, LLC, you will play a critical role in ensuring the quality and integrity of our pharmaceutical products. With a focus on manufacturing and inspection processes, you will be responsible for conducting thorough inspections of tablets, both manually and automatically, to ensure compliance with regulatory...
-
Respiratory Therapy Quality Assurance Specialist
4 weeks ago
Miami Beach, Florida, United States Mount Sinai Medical Center of Florida Full timeRespiratory Therapy Quality Assurance SpecialistJoin Mount Sinai Medical Center of Florida's TeamAt Mount Sinai Medical Center of Florida, we are committed to providing high-quality healthcare to our diverse community. As a Respiratory Therapy Quality Assurance Specialist, you will play a vital role in ensuring that our patients receive the best possible...
-
Quality Assurance Specialist
4 weeks ago
Miami, Florida, United States Insight Global Full timeJob Title: Quality Assurance OfficerAt Insight Global, we are committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.About the Role:We are seeking a highly skilled Quality Assurance Officer to join our team. As a Quality Assurance Officer, you will be responsible for performing quality...
-
Quality Assurance Specialist
2 weeks ago
Miami Gardens, Florida, United States MG STAFFING GROUP Full timeJob Title: Quality Systems SpecialistMG STAFFING GROUP is seeking a highly skilled Quality Systems Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the development and maintenance of quality programs, systems, processes, and procedures that meet regulatory requirements and ensure compliance with policies...
-
Miami, Florida, United States Mount Sinai Medical Center Full timeRespiratory Therapy Quality Assurance SpecialistAt Mount Sinai Medical Center, we are committed to delivering high-quality healthcare to our diverse community. As a Respiratory Therapy Quality Assurance Specialist, you will play a vital role in ensuring the quality of care provided to our patients.Key Responsibilities:Perform routine procedures of the...
