Tissue Quality Assurance Specialist
2 weeks ago
Position Summary
The Tissue Quality Assurance Specialist is tasked with overseeing and executing quality control assessments for human tissue donors, recovered tissues, and finalized processed grafts. This role involves direct communication with external laboratories to gather necessary records and liaising internally with Operations and Quality Assurance to guarantee that suitable samples are prepared for testing and that results are effectively communicated.
Key Responsibilities
- Conduct Quality Control (QC) assessments on tissue samples, including but not limited to residual moisture, sterility, endotoxin levels, bioburden, cell characterization, flow cytometry, microorganism identification, and gram staining.
- Execute QC release testing for microbiological media, materials, and reagents.
- Assist in environmental monitoring (EM) of the facility through routine testing and sample processing.
- Inspect incoming materials and reagents, microbiological media, and both in-process and final products.
- Review and manage test outcomes reported by external parties to ensure appropriate handling of tissues and grafts.
- Maintain accurate documentation of tests conducted in-house and results from third-party testing.
- Prepare blood specimens, tissue samples, and media samples for dispatch to external testing facilities.
- Support the laboratory manager in maintaining inventory of media and reagents and in ordering laboratory supplies.
- Assist in the execution of qualification and validation protocols for QC testing methodologies.
General Duties
- Stay informed about relevant federal and state regulatory requirements as well as standards set by accrediting bodies.
- Report any variances, errors, or deviations to Quality Assurance management and participate in investigations of complaints and deviations, including the development and implementation of corrective actions.
- Engage in audits and inspections as required.
- Support activities related to accreditation and licensing.
- Perform additional tasks as assigned by the QC Manager or Director of Quality Assurance.
Qualifications
Education and Experience: A Bachelor’s degree in a scientific discipline is preferred, or an Associate’s degree in Science with two years of relevant experience. An equivalent combination of education and experience in a regulated environment (e.g., Biologics, Pharmaceutical) will 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. Candidates must demonstrate 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. Knowledge of regulations, laws, and standards governing the tissue banking industry is expected to be acquired within the first year of employment.
Technical Proficiency: Familiarity with Microsoft Office is required. Working knowledge of Vitek 2, Spectrophotometer, Cell Analyzers, Autosampler, and MAGPIX is preferred.
Work Environment: The position primarily involves a fast-paced, laboratory-oriented setting. Evening and weekend work may be necessary.
Physical Requirements: The role necessitates the ability to sit or stand for extended periods. Occasionally, the employee may need to lift or move items weighing up to 20 pounds.
Direct Reports: This position does not have any direct reports.
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