Quality Control Analyst

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Description

Job purpose

The Quality Control Analyst is responsible for performing and managing results of quality control testing for human tissue donors, recovered tissues, and final processed grafts. The QCA communicates directly with outside laboratories to obtain records and internally with Operations and Quality Assurance to ensure appropriate samples are available for testing and results are properly communicated. The QCA performs multiple tests on tissue samples including but not limited to sterility, bioburden, endotoxin, residual moisture, cell count and analytical testing. Must perform all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements.

Duties and responsibilities

Quality Control Testing and Results

• Perform Quality Control (QC) testing of tissue samples to include, but not limited to, residual moisture, sterility, endotoxin, bioburden, cell characterization, flow cytometry, microorganism identification, and gram staining.
• Perform QC release testing of microbiology media, materials, and reagents.
• Support environmental monitoring (EM) of the facility by performing routine testing and processing samples.
• Perform inspection of incoming materials and reagents, microbiology media, and in-process and final product.
• Review and manage test results reported by third parties to ensure proper disposition of tissues and grafts.
• Maintain proper documentation of tests performed in-house and test results reported by third parties.
• Preparation of blood specimens, tissue samples, and media samples for shipment to outside testing facilities.
• Assist Manager in maintaining the laboratory stock of media and reagents and ordering laboratory supplies.
• Support and execute qualification / validation protocols of QC testing methods.

General Responsibilities

• Maintain knowledge of appropriate federal and state regulatory and statutory requirements as well as accrediting body requirements.
• Responsible for reporting all variances, errors, and deviations to QA management. Participate in the investigation complaints and deviations including the formulation and implementation of corrective actions.
• Participate in audits and inspections, as needed.
• Support accreditation and licensing activities.
• Perform other duties as assigned by the QC Manager and/or Director of Quality Assurance.

Requirements

Qualifications

Education/Experience: Bachelor in Science degree preferred or Associate in Science with two years of experience. An equivalent combination of education and experience in a regulated environment (e.g., Biologics, Pharmaceutical, etc.) will be considered.

Laboratory Skills: Aseptic techniques, bioburden, sterility, endotoxin, growth promotion, flow cytometry, gram staining.

Other Skills: Excellent interpersonal, verbal, and written communication skills required.

Must demonstrate excellent organizational and record keeping skills.

Must be detail oriented with the ability to multi-task in a high-pressure environment.

Must gain knowledge of all regulations, laws, and/or standards that govern the tissue banking industry within the first year of employment.

Computer and Equipment: Proficient in Microsoft Office.

Working knowledge of Vitek 2, Spectrophotometer, Cell Analyzers, Autosampler, MAGPIX preferred.

Working conditions

Primarily, a fast pace, lab-oriented work environment. Evening and weekend work may be required.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct Reports

No direct reports.